On December 19, 2016, the FDA published a final rule banning 
powdered gloves based on the unreasonable and substantial risk of 
illness or injury to individuals exposed to the powdered gloves 
(https://www.federalregister.gov/documents/2016/12/19/2016-
30382/banned-devices-powdered-surgeons-gloves-powdered-patient-
examination-gloves-and-absorbable-powder). This guidance document 
has not been updated to reflect the ban. FDA is assessing how to revise 
this guidance to represent our current thinking on medical gloves.  Guidance for Industry and FDA 
Staff  
Medical Glove Guidance Manual  
 
Document issued on January 22, 2008  
 
 
This document supersedes Guidance for Medical Gloves  A Workshop 
Manual, September 30, 1996. 
 
 
For questions regarding this document contact the Infection Control Devices Branch Chief at 
(301) 796-5580.   
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Office of Device Evaluation 
Division of Anesthesiology, General Hospital, 
Infection Control, and Dental Devices 
Infection Control Devices Branch 
  
  Preface 
 
Public Comment 
 
You may submit electronic comments and suggestions at any time for Agency consideration to 
http://www.regulations.gov.  Submit written comments to the Division of Dockets 
Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), 
Rockville, MD  20852.  Identify all comments with the docket number listed in the notice of 
availability that publishes in the Federal Register.  Comments may not be acted upon by the 
Agency until the document is next revised or updated. 
 
 
 
Additional Copies 
 
Additional copies are available from the Internet.  You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance.  Please use the document 
number 1661 to identify the guidance you are requesting 
  Table of Contents 
 
1  PRODUCT IDENTIFICATION ...................................................................................... 2 
2  GLOVE LUBRICANTS .................................................................................................. 8 
3  BIOCOMPATIBILITY.................................................................................................. 10 
4  LABELING.................................................................................................................... 15 
5  PREMARKET NOTIFICATION 510(K)...................................................................... 28 
6  PATIENT EXAMINATION GLOVES ......................................................................... 34 
7  SURGEONS GLOVES ................................................................................................ 43 
8   QUALITY SYSTEM ..................................................................................................... 51 
9  COMPLIANCE ACTIVITIES....................................................................................... 77 
10  VOLUNTARY STANDARDS ...................................................................................... 85 
   
Guidance for Industry and FDA Staff  
 
Medical Glove Guidance Manual  
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking 
on this topic.  It does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public.  You can use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and regulations.  If you want to discuss 
an alternative approach, contact the FDA staff responsible for implementing this 
guidance.  If you cannot identify the appropriate FDA staff, call the appropriate number 
listed on the title page of this guidance.  
 
 
Introduction 
 
This manual provides FDAs recommendations for Premarket Notification (510(k)) 
submissions for medical gloves.  It also provides our recommendations on how to comply 
with the Quality System regulation (21 CFR part 820).  Previous revisions of this manual 
were entitled Guidance for Medical Gloves: A Workshop Manual.  This edition, the 
Medical Glove Guidance Manual (manual), supersedes all earlier revisions and explains 
FDAs current thinking on the requirements and recommendations for medical gloves that 
are marketed in the United States (U.S.).   
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required.  
 
1  1  PRODUCT IDENTIFICATION  
 
 
BACKGROUND ................................................................................................................... 2 
PATIENT EXAMINATION GLOVES ................................................................................ 2 
SURGEONS GLOVES ........................................................................................................ 3 
GLOVES IN KITS ................................................................................................................ 5 
ACCESSORIES..................................................................................................................... 5 
OTHER GLOVE PRODUCTS ............................................................................................. 6 
NON-MEDICAL GLOVES .................................................................................................. 7 
 
BACKGROUND 
 
Introduction 
 
Medical gloves, including surgeons and patient examination gloves, are used to prevent 
transmission of a wide variety of diseases to both patients and health care personnel.  This 
manual contains information on the regulatory requirements for patient examination gloves 
and surgeon's gloves, as well as FDAs recommendations for meeting those requirements.   
 
General Controls 
 
Medical gloves are class I reserved devices and are subject to general controls (section 
513(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (Act); 21 U.S.C. 360c(a)(1)(A)), 
which include: 
  
  Establishment Registration  
  Device Listing  
  Premarket Notification 510(k)  
Labeling 
  Quality System  
  Medical Device Reporting (MDR)  reporting of adverse events associated with a 
medical device. 
 
In addition, foreign firms must name a U.S. Agent (21 CFR 807.40).  You can find additional 
information on medical device regulatory requirements on FDAs Device Advice website at 
http://www.fda.gov/cdrh/devadvice/. 
 
 
PATIENT EXAMINATION GLOVES 
 
21 CFR 880.6250 Patient examination glove. 
 
2  (a)  Identification.  A patient examination glove is a disposable device intended for   
medical purposes that is worn on the examiners hand or finger to prevent 
contamination between patient and examiner. 
(b)  Classification.  Class I (general controls). 
 
Table 1.1  Patient Examination Glove, 21 CFR 880.6250 
 
Common Name  Product Code  
Latex   LYY  
Vinyl (PVC)   LYZ 
Polymer  other than Vinyl  
 LZA 
(includes Nitrile, Polyurethane, etc.) 
Finger Cot    LZB 
Specialty: Chemotherapy, etc.  LZC 
 
 
The subcategories of gloves described in Table 1.1 are all special forms of the category 
patient examination glove.  These gloves should meet the requirements for a patient 
examination glove, as well as additional 510(k) and labeling recommendations described in 
the following paragraphs:    
 
Specialty/Chemotherapy Labeling Claim.  Medical gloves cleared for marketing with 
chemotherapy labeling claims (often referred to as chemotherapy gloves) are specialty 
patient examination gloves.  These gloves should meet the current FDA-recognized 
consensus standard for patient examination gloves or an equivalent test method.   
We recommend that you follow the 510(k) format for examination gloves outlined in Chapter 
6 for chemotherapy glove 510(k) submissions.  The 510(k) submission should also include 
permeation and penetration data based on actual testing with chemotherapeutic drugs. 
 
For additional information, refer to Chemotherapy Labeling Claim in Chapter 4.   
 
Dental Patient Examination Gloves.  Gloves worn during dental cleaning, filling, and other 
dental procedures are patient examination gloves.  These gloves should meet the 
requirements for patient examination gloves.  You may use the term "dental" in the labeling 
of gloves intended for dentistry.  The term dental should always be used with, and does not 
replace, the term patient examination glove. 
 
SURGEONS GLOVES 
 
21 CFR 878.4460 Surgeons glove. 
 
(a)  Identification.  A surgeons glove is a device made of natural or synthetic rubber 
intended to be worn by operating room personnel to protect a surgical wound from 
contamination.  This excludes the lubricating or dusting powder used in the glove. 
 
3  (b)  Classification.  Class I (general controls). 
 
Surgeons gloves are subject to the design control requirements of the Quality System 
regulation (21 CFR 820.30(a)(2)(ii)).   
 
Surgeons gloves should be sterile when offered for sale to end users, such as hospitals, 
clinics, and surgeons.  FDA has not cleared any 510(k)s for non-sterile surgeons gloves.  A 
510(k) submission for surgeons gloves should include information about the sterilization 
method and cycle.  The provisions in 21 CFR 801.150(e) regulate the shipment of medical 
gloves to and from a contract sterilizer.  See Chapter 8 for additional information. 
 
Table 1.2  Surgeon's Glove, 21 CFR 878.4460 
 
Common Name  Product Code  
Surgeons Glove (including Dental Surgeons gloves)  
Microsurgery Glove  
Orthopedic Surgeons Glove 
KGO 
Autopsy Surgeons Glove  
Specialty/Chemotherapy Surgeons Glove  
Radiation Attenuating Surgeons Gloves 
 
 
The subcategories of gloves described in Table 1.2 are all special forms of the category 
surgeons glove.  These gloves should meet the requirements for a surgeons glove as well 
as additional 510(k) and labeling recommendations described in the following paragraphs: 
    
Dental Surgeons Glove.  You may use the term "dental" in the labeling of gloves intended 
for dental surgery.  Gloves for dental surgery may be thicker than standard surgeons gloves.  
The labeling may include the measured thickness of the gloves, but you should not use 
ambiguous terms such as "extra thick."  
 
Microsurgery Glove.  Microsurgery gloves are carefully processed to have decreased 
thickness in certain areas, particularly at the fingertips.  To date FDA has not cleared any 
510(k) submissions for microsurgery gloves that are thinner than the specifications in the 
FDA-recognized consensus standard for surgeons gloves.  As with all surgeons gloves, 
testing should demonstrate safety and effectiveness for its indications for use.  
 
Orthopedic Surgeons Glove.  Orthopedic surgical gloves may be larger, thicker, and more 
resistant to tear than other surgical gloves.  You may state the measured thickness and other 
parameters of orthopedic gloves in the labeling.  You should not use ambiguous terms, such 
as "extra thick," or "super strong."  
 
Autopsy Surgeons Glove.  Autopsy gloves are intended for use during autopsy procedures 
and may be similar to orthopedic surgeons gloves.  These gloves are subject to the same 
regulatory requirements as surgeons gloves.  
 
4  Specialty/Chemotherapy Labeling Claim.  We recommend that you follow the 510(k) 
format for surgeons gloves outlined in Chapter 7 for chemotherapy glove 510(k) 
submissions.  The 510(k) should also include permeation and penetration data based on 
actual testing with chemotherapeutic drugs.  We recommend that surgeons gloves with 
chemotherapy labeling claims  follow the current FDA-recognized consensus standards for 
surgeons gloves or an equivalent test method.   
 
For additional information, refer to Chemotherapy Label Claim (under Attribute Labeling) in 
Chapter 4.   
 
Radiation Attenuating Surgeons Glove.  Radiation attenuating surgeons gloves are used 
during surgical procedures involving radiation exposure to the hands.  The gloves offer some 
degree of protection to the hand from radiation exposure as well as protection from 
transmission of infectious agents.  The use of these gloves includes surgical procedures that 
require the use of fluoroscopy or radiography.  In addition to meeting the requirements for a 
surgeons glove, manufacturers should have technical data to show that their attenuation 
claims meet the energy range of x-rays normally used in medical procedures. 
 
GLOVES IN KITS 
 
A medical device kit may include medical gloves.  Kit manufacturers and assemblers should 
assure that gloves in their kits are cleared for marketing and that the gloves can meet the 
appropriate FDA and ASTM standard (such as ASTM D3577, ASTM D3578, ASTM D5250, 
ASTM D6319) or an equivalent test method after the kit is sterilized.   
 
We recommend that you enclose natural rubber latex gloves in their own packaging within 
the kit to avoid possible protein contamination of other devices.  You must label the kit 
appropriately for any device or packaging containing natural rubber (21 CFR 801.437).   
 
You may refer to the following documents for additional guidance: 
 
Convenience Kits Interim Regulatory Guidance 
http://www.fda.gov/cdrh/ode/convkit.html  
 
Sterilized Convenience Kits for Clinical and Surgical Use 
http://www.fda.gov/cdrh/comp/guidance/1390.html  
 
ACCESSORIES  
 
Table 1.3 Classification codes for accessories 
 
Common Name  Product Code  Regulation Number 
Glove Liners/Undergloves   KGO   21 CFR 878.4460 
Surgeons Gloving Cream   KGQ   21 CFR 878.4470 
5   
Glove Liners/Undergloves.  Glove liners or undergloves are worn with patient examination 
or surgeons gloves.  They may be made of materials such as cotton to prevent the medical 
glove from contacting the users hand, or they may be made of materials that are resistant to 
cutting or puncture.  The glove liners provide added protection by reducing the risk of a cut 
or puncture wound during surgical or examination procedures and by absorbing perspiration.  
Unless separately classified, accessories to medical gloves have the same classification 
(regulation number) as the gloves with which they are used. 
 
Medical device regulations apply to glove liners and undergloves.  Because glove liners and 
undergloves contact the skin, you should submit biocompatibility data with a 510(k) 
submission to show that they are safe for their intended use (See Chapter 3, 
Biocompatibility).  If your labeling states that your glove liners provide a protective barrier, 
then the glove liners should meet the quality limit for barrier defects (pinholes) in the FDA-
recognized consensus standard (or an equivalent standard) for the glove to which the liner is 
an accessory. 
 
Surgeons Gloving Cream.  Surgeons gloving cream lubricates the users hand before 
putting on a surgeons glove.  This cream may also be used with examination gloves.  FDA 
classified gloving cream as a class I device under 21 CFR 878.4470.  Gloving cream is 
exempt from 510(k) submission requirements unless the intended use of the cream is 
different from that described in 21 CFR 878.4470, i.e., "lubricating the user's hand...."  
Gloving creams should not degrade the glove material in latex gloves or other gloves, i.e., the 
creams should not be oil-based.  If a manufacturer modifies the ingredients of an existing 
gloving cream or introduces a new gloving cream into commercial distribution, the 
manufacturer should ensure that the cream performs as claimed.  The manufacturer also 
should maintain biocompatibility data on file to show that the new or modified cream is safe 
and effective for the intended use.   
 
OTHER GLOVE PRODUCTS 
 
Radiographic Protection Glove.  FDA classified radiographic protection gloves as a 
"personnel protective shield" under 21 CFR 892.6500 (product code IWP).  This is a class I 
device and is exempt from Premarket Notification (510(k)).  The gloves are intended to 
protect the operator, patient, or other person from unnecessary exposure to radiation during 
radiological procedures by providing an attenuating barrier to radiation.  We recommend that 
you maintain technical data to show that their attenuation claims meet the energy range of x-
rays normally used in medical procedures. 
 
If radiographic protection gloves are also intended for use as medical gloves, FDA classifies 
them as either patient examination gloves or surgeons gloves and they are subject to 510(k) 
clearance.  
 
Leak Detectors.  Leak detectors are chemical, electromechanical, or electronic systems 
designed for the glove user to monitor glove barrier integrity immediately before and during 
6  glove use.  FDA classifies these devices as accessories to medical gloves.  Leak detectors 
used as medical devices should have 510(k) clearance before marketing.   
 
Leak testers and other equipment used during the production of gloves are production 
equipment; they are not medical devices.  The Quality System regulation in 21 CFR 820.70 
and 820.72 covers the selection, use, control, and maintenance of production equipment.  
 
NON-MEDICAL GLOVES 
 
Embalming Gloves.  The Occupational Safety and Health Administration (OSHA) regulates 
embalming gloves. 
 
Food Service Gloves.  FDA considers food service gloves to be a food contact surface which 
may result in the addition of indirect food additives to the food handled.  FDAs Center for 
Food Safety and Applied Nutrition (CFSAN) regulates food service gloves.  
 
Gloves used for food handling or preparation are not medical devices; therefore, they are not 
subject to the 510(k) premarket review process and thus are not cleared for marketing by 
FDAs Center for Devices and Radiological Health (CDRH).  Labeling of food service 
gloves should not, in any way, represent or suggest that they may be used for medical 
purposes.  This may include the brand name and company name. 
 
For further information regarding additives and food use of gloves, contact CFSAN at 
301-436-2600 (phone) or oco3@cfsan.fda.gov (email). 
  
The National Sanitation Foundation (NSF) has developed a protocol for food service gloves 
identified as P155: Disposable Food Contact Gloves.  This document is available at 
http://www.nsf.org/. 
 
Cleaning Gloves.  FDA does not regulate gloves that are used for routine janitorial functions 
in medical facilities.  However, gloves that are used for cleaning patients, or cleaning or 
handling surfaces or items contaminated with patient waste or fluids are medical gloves and 
should meet the requirements for patient examination gloves.   
 
Utility, industrial, or general purpose gloves are used for tasks that do not involve contact 
with patients or body fluids.  Therefore, FDA does not regulate them as medical devices.  It 
is illegal for manufacturers to relabel these gloves for medical use or to imply in their 
labeling that the gloves are suitable for medical use.  Labeling of utility, industrial, and 
general purpose gloves should not, in any way, represent or suggest that they may be used for 
medical purposes.  This may include the brand name and company name. 
 
7  2  GLOVE LUBRICANTS 
 
ABSORBABLE DUSTING POWDER ................................................................................ 8 
COAGULANTS AND RELEASE AGENTS ....................................................................... 9 
 
ABSORBABLE DUSTING POWDER  
 
Donning lubricants such as cornstarch and silicone may make it easier to put on medical 
gloves.  Powdered lubricants are also called donning powders or dusting powders.  Powder 
from medical gloves directly contacts wounds, body cavities, and skin and can contaminate 
both the patients and the users environment.  FDA believes it is important to minimize the 
amount of powder on finished gloves.  We recommend that you establish a specification for 
the amount of powder on a glove and a procedure to verify that powder levels on finished 
gloves meet that specification.   
 
A small amount of silicone or other lubricant is also used on some powder-free gloves to aid 
in donning.  If used, the lubricants should be on the finished gloves when you conduct 
biocompatibility tests.  You should identify the complete chemical characterization/chemical 
formulation of the lubricant in the 510(k) submission. 
 
Examination Gloves.  Cornstarch that meets the specification for absorbable donning or 
dusting powder in the United States Pharmacopeia (U.S.P.) is a commonly used lubricant for 
examination gloves.  Any powder used for lubricating examination gloves should meet the 
U.S.P. monograph for absorbable dusting powder or be equivalent in terms of safety and 
effectiveness.  The 510(k) submission should state the type, specifications, and source of 
powder or other donning lubricant used on the gloves.  You should not use talc, cotton flock, 
and other non-absorbable materials as a lubricating, dusting, or donning powder.  Recognized 
consensus standards specify that the inside and outside surface of medical gloves be free of 
talc.  Lycopodium (club moss spores) and ground pine pollen are toxic.  You should not use 
them as powder on or in medical gloves.   
 
Surgeons Gloves.  Absorbable dusting powder for lubricating a surgeons glove is a 
transitional device (a device formerly regulated as a new drug before l976).  FDA classifies it 
as a class III medical device under 21 CFR 878.4480 (product code KGP).  Absorbable 
dusting powder for lubricating a surgeons glove requires an approved Premarket Approval 
Application (PMA) or, if marketed prior to May 28, l976, a New Drug Application (NDA).  
You may use only absorbable dusting powders manufactured under an approved PMA or 
NDA on powdered surgeons gloves. 
 
A current list of approved NDAs or PMAs for Surgical Dusting Powder is available through 
the PMA database on the FDA website.  Place KGP in the Product Code box and click on 
Search. 
 
PMA database: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm 
8   
Guidance on the content and format for a PMA for Absorbable Powder for Lubricating a 
Surgeons Glove is available at: 
 
Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a 
Surgeons Glove 
http://www.fda.gov/cdrh/ode/guidance/1230.html 
 
Device Advice PMA  
http://www.fda.gov/cdrh/devadvice/pma/  
 
COAGULANTS AND RELEASE AGENTS 
 
In order to have uniform distribution of the latex mix on the mold, commonly called a 
former, the mold is first dipped in a coagulant solution usually containing a calcium salt in 
water.  In addition, the coagulant solution sometimes contains a lubrication agent to facilitate 
stripping (removing) the gloves from the molds at the end of the production line.  A small 
amount of the coagulant and release agent remains on the "inside" surface of the glove.  In 
some processes, washing removes most of the mold release agent from the surface of the 
glove.  If these manufacturing material residues can adversely affect the safety or 
effectiveness of the gloves, you must establish and maintain procedures for the use and 
removal of the manufacturing material to ensure that it is removed or limited to an amount 
that does not adversely affect the gloves's quality (21 CFR 820.70(h).  
 
 
9  3  BIOCOMPATIBILITY 
 
 
INTRODUCTION ............................................................................................................... 10 
SKIN IRRITATION AND DERMAL SENSITIZATION STUDIES ................................ 11 
COLOR AND FLAVOR ADDITIVES ............................................................................... 12 
LAB DIRECTORY ............................................................................................................. 13 
 
INTRODUCTION 
   
We recommend that you conduct biocompatibility testing as described in the guidance 
entitled, Use of International Standard ISO-10993, Biological Evaluation of Medical 
Devices Part 1: Evaluation and Testing, available at http://www.fda.gov/cdrh/g951.html  on 
finished gloves.  You should select biocompatibility tests appropriate for both surface and 
external communicating devices with limited duration (24 hours) of contact.  Because 
medical gloves are in direct contact with skin, a primary skin irritation study and a dermal 
sensitization study are appropriate.   
 
You should perform biocompatibility tests on finished gloves.  The gloves used for 
biocompatibility studies should contain the same colorants, fragrances, flavors, powders, 
lubricants, and processing chemicals.  You should test gloves that have been processed, 
packaged, and if appropriate, sterilized by the same methods as the gloves you will distribute.  
You should consider the need to repeat biocompatibility studies if you make subsequent 
changes in glove composition, manufacturing materials, or processing. 
 
The 510(k) submission should include biocompatibility test results and other information and 
data described in this manual as an attached report for each major study or test program.  You 
should identify all reports or attachments with the manufacturers name, number the pages, 
and list the reports or attachments in the table of contents.  For sterile devices, test data 
should include the results of tests performed using the finished sterilized devices. 
  
You and the contract laboratory, if used, should check the: 
 
  logical presentation of the biocompatibility data, 
  scientific soundness of the test method and data analysis, 
  relevance of the test program to the device and the intended use, and 
  completeness of the summary report of the tests or studies.   
 
We recommend that you present the summary of test results in a table format in each report 
whenever possible.  Each study or test attachment report should contain sufficient and well-
organized information in reasonable detail so that the FDA reviewer can determine: 
 
10    what exact material or device was tested,  
  what tests were performed,  
  how the tests were performed, and  
  what were the test results.   
 
We recommend that you  submit reasonable and sufficient details of all test procedures and 
results to FDA.  For biocompatibility studies, you should use a standard scoring system for 
each test method, if a standard scoring system exists.  We recommend each test report  
include the following: 
 
  name and address of the manufacturer of the item tested, 
  name and technical description of the item tested, 
  name and address of the laboratory where the tests were conducted, 
  test methods, including the scoring method, 
  number of samples and replicates tested, 
  control data needed to establish the validity of the test, 
  date when the tests were conducted, 
  summary report(s) of results obtained, and 
  analysis, interpretation of results, and conclusions. 
 
You should keep the original records of the study on file. For surgeons gloves, the records 
should be maintained as part of your design verification records in the design history file.  
You should also maintain the original records when a study, such as a biocompatibility study, 
is conducted by a contract laboratory to establish a device specification and/or to obtain data 
for a submission to FDA.  The original document should include the name and address of the 
laboratory and device manufacturer, the device identity, and dates of testing.  You should not 
submit the original records to FDA.  During factory inspections, FDA investigators may ask 
to see these original records.   
 
SKIN IRRITATION AND DERMAL SENSITIZATION STUDIES  
 
The following is a general discussion of how to conduct the skin irritation and dermal 
sensitization studies.  Because methods may vary from laboratory to laboratory, the test data 
you submit to FDA should contain a brief description of the test protocol, scoring criteria 
used, and the method used for rating skin responses.   
 
Primary Skin Irritation Test (Animal Study) 
Performing skin irritation testing demonstrates the irritation potential of the gloves, i.e., for 
initiating or aggravating damage through its contact with the skin.  We recommend that you 
perform the primary skin irritation testing according to the regulations of the Consumer 
Product Safety Commission (16 CFR 1500.41). We recommend that you identify the inside 
and outside of the gloves so that both sides are tested, i.e., approximately half of the test 
articles expose opposite sides of the glove to the subject.   
 
11  Dermal Sensitization Study (Animal Study) 
The purpose of performing dermal sensitization is to demonstrate the potential of the device 
for eliciting a delayed hypersensitivity (Type IV) immunologic response through its contact 
with the skin.  This reaction is due primarily to substances which could leach out of a 
material.  Guinea pigs are used because they have been shown to be the best animal model 
for human allergic contact dermatitis.  We recommend the method described in  ASTM  
standard F720-86, Standard Practice for Testing Guinea Pigs for Contact Allergens, Guinea 
Pig Maximization Test, for the study.  Laboratories may also use the method of Buehler, as 
reported in Archives of Dermatology (1965).  Dermal sensitization studies use two tests or 
phases: the induction phase and challenge phase.  You should identify the inside and outside 
of the gloves so that both sides are tested, i.e., approximately half of the test articles expose 
opposite sides of the glove to the subject. 
 
Testing for Skin Sensitization to Chemicals 
Your labeling may include special claims regarding reduced potential chemical sensitization 
in a 510(k), such as: 
  reduced potential for sensitizing users to rubber chemical additives or, 
  reduced potential for causing reaction in individuals sensitized to rubber chemical 
additives. 
You should support these claims by data from human testing.  Additional guidance on testing 
for skin sensitization to chemicals in latex products is available in the following guidance 
document:  
 
Premarket Notification [510(k)] Submissions for Testing for Skin 
Sensitization to Chemicals in Natural Rubber Products  
http://www.fda.gov/cdrh/ode/944.html 
 
If you have already conducted a Modified Draize Test (MDT) on a minimum of 200 human 
subjects to support a reduced sensitization claim, you may use the MDT data instead of the 
primary skin irritation test (animal) and dermal sensitization study (animal) typically used to 
support the general biocompatibility of medical gloves.   
 
COLOR AND FLAVOR ADDITIVES 
 
You should show that any substance added to the gloves, including color, flavor, and/or scent 
additives, does not adversely affect the safety or effectiveness of the gloves.  Therefore, if a 
device contains a color or other chemical additive and the device is intended to be in contact 
with the skin or other parts of the body, you should submit biocompatibility data to 
demonstrate the safety of the additives, unless you can establish that the additives would not 
leach and contact the body. 
 
FDA considers the addition of color, flavor, or any chemical to a medical glove to be a 
significant change that should have a new 510(k) submission (21 CFR 807.81(a)(3)). You 
12  should provide full characterization and chemical identity of the color, flavor, or scent 
additives.  You may submit a 510(k) submission for a modification to an existing glove as a 
Special 510(k).  Additional information about Special 510(k) submissions is available at 
http://www.fda.gov/cdrh/devadvice/3144.html. 
         
You can find color additive and flavor additive regulations in 21 CFR parts 70 to 82 and 21 
CFR part 172, Subpart F, respectively.  Note that color and flavor additives contained in 
these regulations are specific to foods, drugs, and cosmetics.  The color additive regulations 
should not be confused with the general 510(k) requirements, which are independent of the 
color additive listing and certification mentioned above.  You should show that any color or 
flavor substance added to a device does not adversely affect the safety or effectiveness of the 
device.  Gloves that contain FDA-approved color or flavor additives for foods, drugs, or 
cosmetics should undergo biocompatibility testing to demonstrate the safety of the additives 
in the device.  We may accept other color or flavor additives not contained in these 
regulations with appropriate biocompatibility testing. 
 
Medical device labeling requirements do not require the glove box or carton to have an 
"ingredient statement" listing the flavor agent, colorant, or other additives used in the 
manufacture of the glove.  However, manufacturers may do so voluntarily. 
 
See Chapter 4 for labeling considerations for medical gloves with color and flavor additives. 
 
LAB DIRECTORY 
 
The websites below may be helpful in finding a testing laboratory.  FDA does not certify 
testing laboratories.  As with any supplier of services, you should verify the adequacy of the 
services offered (21 CFR 820.50(a)). 
 
The American Association for Laboratory Accreditation 
http://www.a2la2.net/ 
 
American Council for Independent Laboratories 
http://www.acil.org/  
 
ASTM International 
http://www.astm.org/LABS/ 
 
Canon Communications 
http://www.devicelink.com/consult/BiocompatibilityToxicology.html  
http://www.devicelink.com/company98/category/Testing_Equipment_and_Services/i
ndex.html  
 
Findtesting.com 
http://www.findtesting.com/directory/category.asp?category=biological&page=7 
 
13  Thomas Register 
http://www.thomasnet.com 
Search categories include: 
Testing Services: Safety 
Testing Services: Latex 
Testing Services: Medical Equipment 
Testing Services: Medical Device 
International Testing & Compliance Services 
Product Safety Testing Services 
14  4  LABELING  
 
BASIC LABELING ............................................................................................................ 15 
DEVICES THAT CONTAIN NATURAL RUBBER......................................................... 16 
EXPIRATION DATE LABELING..................................................................................... 17 
DONNING POWDER OR LUBRICANT IDENTIFICATION ......................................... 19 
ATTRIBUTE LABELING .................................................................................................. 19 
STANDARDS ..................................................................................................................... 23 
LOT NUMBER ................................................................................................................... 23 
BAR CODING .................................................................................................................... 23 
EXAMPLE LABELING ..................................................................................................... 24 
 
BASIC LABELING  
 
You can find general labeling requirements for all medical devices in 21 CFR part 801.  
Specific labeling requirements for devices made from natural rubber latex are provided in 21 
CFR 801.437.   
 
Name and Place of Business  
 
  The label of a glove should contain the name and place of business of the 
manufacturer, packer, or distributor, including the street, address, city, state, and zip 
code.  If the street address of the identified manufacturer, packer, or distributor is in 
the local (U.S.) telephone directory, you can omit the street address. (21 CFR 
801.1(a) and (d)).   
  If the firm identified on the label is not the manufacturer, then you should qualify the 
firms name by an appropriate statement such as, Manufactured for... or 
Distributed by.... (21 CFR 801.1(c)). 
 
Country of Origin 
 
The label must contain the country of origin if other than the U.S. (19 CFR 134.11).  The 
U.S. Customs and Border Protection enforces this regulation. 
 
Statement of Identity (21 CFR 801.61) 
 
  The statement of identity of the glove must be on the principal display panel.  The 
principal display panel, means ...the part of a label that is most likely to be 
displayed, presented, shown, or examined under customary conditions of display for 
retail sale. (21 CFR 801.60).  
 
  If the glove is made of a synthetic polymer, the statement of identity should include 
the common, generic, or scientific name of the polymer used.  The term "synthetic" 
15  used alone does not fully characterize the composition of the glove and may mislead 
the purchaser.  If you manufacture the glove from a blend of polymers, you should 
identify each component, including any blend containing natural rubber latex.   
 
  The identity statement must list the common name of the device (21 CFR 801.61(b)). 
Examples include powdered latex surgeons gloves, powdered latex patient 
examination gloves, powder-free latex surgeons gloves, powder-free latex patient 
examination gloves, latex finger cots, powdered nitrile examination gloves, and 
powder-free vinyl examination gloves.  You should not use undefined terms such as 
low-powder.  
 
  The identity statement must be in bold face type, reasonably related in size to the 
most prominent printed matter on the display panel, and in lines generally parallel to 
the base of the package when rested (21 CFR 801.61(c)).   
 
Language  
 
All labeling must be in English with the exception of those products distributed solely within 
Puerto Rico or a U.S. Territory where the predominant language is not English (21 CFR 
801.15(c)(1)).  If any representation on the device label or labeling appears in a foreign 
language, then all required labeling must also appear in that foreign language (21 CFR 
801.15(c)(3)).   
 
Net Quantity of Contents Statement  
 
The label must contain a statement of net quantity of contents in terms of weight, measure, 
numerical count, or statements of both numerical count and weight, measure, or size (21 CFR 
801.62(a)).  Whichever statement of net quantity of contents you use, you should state it 
clearly and understandably on the label, e.g., 100 gloves, packaged by weight. 
 
The net quantity declaration must appear as a separate item in the lower 30 percent of 
each principal display panel.  You must separate it, by at least a space equal to the height 
of the lettering used in the declaration, from other information appearing above and 
below.  Also, you must separate the declaration by at least twice the width of the letter 
N from labeling to the left or right. (21 CFR 801.62(e)). 
 
Adequate Directions for Use   
 
You should label disposable medical gloves as "single use only."  The label for surgeons 
gloves should contain any necessary directions for use.   
 
DEVICES THAT CONTAIN NATURAL RUBBER  
 
Caution Statement.  If your medical gloves contain natural rubber latex, you must put the 
following statement in bold print on the device labeling: 
16   
Caution:  This Product Contains Natural Rubber Latex Which May Cause 
Allergic Reactions.  
 
This statement must appear on all device labels, and other labeling, as well as on the 
principal display panel of the device packaging, the outside package, container, or wrapper, 
and the immediate device package, container, or wrapper (21 CFR 801.437(d)). 
 
EXPIRATION DATE LABELING  
  
Expiration date labeling for medical gloves is voluntary.  However, if you make an expiration 
date labeling claim, the gloves should meet the performance characteristics and specifications 
presented in the Premarket Notification (510(k)) over the entire claimed shelf life.  
Manufacturers with cleared 510(k) submissions for surgeons or patient examination gloves 
do not have to submit new 510(k) submissions to add an expiration date to the labeling. 
 
You should perform real-time stability studies in order to determine an expiration date.  The 
stability studies should include tests to verify that medical gloves maintain their barrier 
properties, physical properties, packaging integrity, sterility, and any specific attributes 
claimed in the labeling over the entire shelf life of the glove.  We recommend the following 
tests: 
 
  Barrier property tests.  You should perform the FDA 1000 mL Water Leak Test (21 
CFR 800.20) or ASTM International (ASTM) D5151, Standard Test Method for 
Detection of Holes in Medical Gloves to assess barrier integrity.   
 
  Physical properties tests.  You should use appropriate physical properties tests such 
as those in ASTM D3577, Standard Specification for Rubber Surgical Gloves; ASTM 
D3578, Standard Specification for Rubber Examination Gloves; ASTM D5250, 
Standard Specification for Poly (vinyl chloride) Gloves for Medical Application; 
ASTM D6319, Standard Specification for Nitrile Examination Gloves for Medical 
Application; or an equivalent appropriate physical property test.   
 
  Sterility and package integrity tests.  You should test sterile glove packaging for 
package integrity and the ability to maintain sterility.  Documentation should include 
evidence that, after storage, the product packaging still meets the manufacturers 
specifications for package integrity. 
 
  Tests to support labeling claims.  You should test for properties that may be 
adversely affected by product aging, such as resistance to chemicals.  Manufacturers 
should document this testing.   
 
Manufacturers/sponsors may use test protocols from the applicable voluntary consensus 
standards or may develop their own protocols for stability testing.  If you develop original 
protocols, you should describe the protocols in detail (test methodology, acceptance criteria, 
17  time intervals for testing).  You should give a rationale for any variation from the applicable 
consensus standard.  Manufacturers should maintain the originals of all protocols, test 
reports, and identification of persons/labs performing the test at their manufacturing 
establishment so that the information is available for review during an FDA inspection. 
   
Provisional Expiration Date 
 
FDA will accept a provisional expiration date of up to 3 years from the date of manufacture 
based on accelerated aging studies, provided the manufacturer immediately initiates real-time 
stability testing to obtain data to support the proposed expiration date.  You should perform 
accelerated aging studies at a minimum of two elevated temperatures between 40 and 80 
degrees C.  If the product does not meet the required criteria after accelerated aging, you 
should label the product with a shelf life determined by real-time testing.  FDA believes that 
expiration dates based on real time data should not exceed 5 years from the date of 
manufacture.  If the real-time data do not support the expiration date based on accelerated 
aging, you should change the expiration date to reflect actual shelf life.  
 
Test Reports 
 
We recommend that you generate test reports to document both the real-time and accelerated 
aging of the gloves.  Test report documentation should be consistent with the appropriate 
standards.  In addition, we recommend that each test report should include the following 
information:  
 
  product identification, including lot numbers and date of manufacture 
  test method identification, including documentation for in-house procedures 
  sample size and acceptance criteria for each test conducted 
  description of product packaging during storage (e.g., individually packaged, standard 
sterile packaging) 
  description of storage environment (temperature and humidity) and duration of 
storage  
  time elapsed between date of manufacture and each testing interval 
  raw test data, including an appropriate statistical summary 
  data analysis 
  conclusion, including the shelf life supported by the data. 
 
Labeling 
 
When you establish the shelf life of the gloves using real time stability testing, or when you 
establish a provisional shelf life using accelerated aging, the expiration date labeling on 
medical gloves should conform with the following: 
 
1.  You can obtain the expiration date for a specific lot of gloves by adding the 
established shelf life to the date of manufacture for that lot.  The date of 
manufacture refers to the date of completion of the final step of the manufacturing 
process (final packaging or sterilization).   
18   
2.  The expiration date should state the month and year of the shelf life.  You should 
express the expiration date by spelling out the name of the month followed by the 4-
digit year, e.g., January 2006.  You should not express the date as 1/10/06 because 
this may be interpreted as October 1, 2006, in some parts of the world, resulting in the 
use of outdated and degraded gloves.   
 
3.  The expiration date, stated as Use Before: [date] should be prominently displayed 
on the exterior of the primary and retail package and on the shipping carton. 
 
4.  Sterile surgeons and patient examination gloves that have an expiration date based 
on sterility that is different from the expiration date based upon physical and 
mechanical integrity testing should bear only the earlier expiration date.  
 
ASTM International developed the following standards for expiration dating of medical 
gloves: 
 
  D7160-05 Standard Practice for Determination of Expiration Dating for Medical 
Gloves  
  D7161-05 Standard Practice for Determination of Real Time Expiration Dating of 
Mature Medical Gloves Stored Under Typical Warehouse Conditions  
 
You can obtain more information on these standards directly from ASTM at 
http://www.astm.org.  
 
DONNING POWDER OR LUBRICANT IDENTIFICATION  
 
If surgeons gloves are powdered, they must be powdered with an absorbable dusting powder 
that has received FDA approval under either an NDA or a PMA (21 CFR 878.4480). The 
labeling should inform users with a statement such as, Powdered with absorbable dusting 
powder.  Absorbable powder for lubricating a surgeons glove is a Class III medical device 
under 21 CFR 878.4480.  For more information about glove lubricants, see Chapter 2 of this 
manual. 
 
If patient examination gloves are powdered, the powder should meet the United States 
Pharmacopoeia (U.S.P.) monograph for absorbable dusting powder or demonstrate 
equivalence in terms of safety and effectiveness.  U.S.P powder is commonly used on 
examination gloves so the corresponding labeling statement should read, Powdered with 
absorbable dusting powder, U.S.P. 
 
ATTRIBUTE LABELING 
 
In addition to basic labeling described above, manufacturers may have labeling claims for the 
attributes of their gloves.  Some attributes are color, flavor, scent, and thickness.  You should 
19  submit data to support all claims in your 510(k).  You should not use ambiguous labeling 
claims such as extra thick or super-sensitive because they are misleading.  You should 
use acceptable factual and definitive statements, such as the actual glove thickness as 
determined by measurement.   
 
Section 502 of the Act prohibits labeling that is false or misleading in any way (21 U.S.C. 
352).  Any labeling claim should describe the device truthfully and accurately.  See Chapter 
9, Compliance Activities, for more information on labeling. 
 
Powder-Free 
 
Gloves with trace amounts of residual former-release powder (2 mg or less per glove) and no 
intentionally added donning powders are commonly referred to as powder free.  Most 
manufacturers dip the glove mold, known as a former, into a solution of calcium carbonate 
and calcium nitrate.  After controlled drying, manufacturers dip the coated former into the 
latex solution and create a glove on the former.  The calcium carbonate helps release the 
glove from the former.  An extremely small amount of calcium carbonate remains on the 
glove.  Most of it is removed by leaching and washing.   
 
FDA has recognized standard method ASTM D6124, Standard Test Method for Residual 
Powder on Medical Gloves, for collecting and measuring the manufacturing debris, residual 
former-release powder, and other elements on a powder-free glove or the powder levels on 
powdered medical gloves. 
 
To establish a powder-free claim, FDA recommends that you have no more than 2 mg of 
residual or trace powder and debris per glove, as determined by the ASTM D6124 test 
method (Standard Test Method for Residual Powder on Medical Gloves) or an equivalent 
method.   
 
Protein Label Claims 
 
Latex proteins can cause Type I sensitivity in some individuals who have been exposed to 
latex-containing devices.  Repeated exposure to latex proteins may increase the probability 
that an individual will become sensitized.  Since May 1991, the FDA has recommended that 
manufacturers of latex devices reduce the water-extractable protein on their natural rubber 
latex devices.  FDA considers water soluble latex proteins to be concomitant constituents, 
which are manufacturing materials under the Quality System regulation, 21 CFR 820.3(p). 
FDA requires the reduction of these types of materials according to 21 CFR 820.70(h).   
 
Manufacturers who can reliably reduce the levels of latex proteins in their gloves to a known 
level may make a labeling claim, if they submit supporting data in their 510(k) submission.  
At present, FDA does not allow a protein labeling statement or claim below the current 
50g/dm2 sensitivity limit of the ASTM Lowry test method (D5712).  Work is being done to 
determine the sensitivity and detection limits of the ELISA test method (ASTM D6499).  At 
the time of this writing, these limits are unknown. 
  
20  FDA suggests that you measure the natural rubber latex protein on recently manufactured 
finished gloves that have undergone accelerated aging according to the ASTM standard 
D3578 (Standard Specification for Rubber Examination Gloves) or D3577 (Standard 
Specification for Rubber Surgical Gloves) or real time aging.  Water soluble proteins may 
migrate to the glove surface during shipping.  Aging should approximate this time period. 
 
If you label your gloves as containing 50g/dm2 or less per glove of extractable protein, the 
labeling should also state: 
 
Caution: Safe use of these gloves by latex sensitized individuals has not been 
established. 
 
You must ensure that any labeling changes to dispenser boxes and any changes to 
manufacturing processes meet the requirements of the Quality Systems regulation in 21 CFR 
820.30 (for surgeons gloves), 820.40 and 820.70.  See Chapter 8, Quality System, for further 
guidance.  
 
Chemical Sensitization 
 
Certain chemicals routinely used in the manufacture of medical gloves, such as natural 
rubber latex and other materials, can cause skin sensitization and irritation.  If you  
sufficiently reduce or eliminate the presence of these chemicals, you  may make appropriate 
labeling claims regarding the reduced potential of chemical sensitization or reduced reaction-
inducing potential of your gloves in allergic individuals if cleared in a 510(k) submission.  
You can find guidance about reduced sensitization claims for latex gloves in the guidance 
document Premarket Notification (510(k)) Submissions for Testing for Skin Sensitization to 
Chemicals in Natural Rubber Products at http://www.fda.gov/cdrh/ode/944.html.  Refer to 
Chapter 3, Biocompatibility, for additional information on biocompatibility. 
 
Color and Flavor Additives 
 
Medical device labeling does not require an ingredients statement listing the flavor agents 
or colorants used in the manufacture of the gloves on the glove box or carton.  However, 
manufacturers may do so voluntarily. 
 
FDA considers the addition of colorants, other than traditional whiteners, such as titanium 
dioxide or the addition of a flavoring agent to a medical glove, to be a significant change 
which should have 510(k) clearance (21 CFR 807.81(a)(3)). The new finished glove should 
undergo full biocompatibility testing.   
 
Chemotherapy Label Claim 
 
Medical gloves with a chemotherapy claim should meet an appropriate FDA-recognized 
consensus standard for medical gloves or an equivalent test method.  Physical features such 
as increased thickness and length make these gloves more suitable for the safe handling of 
chemotherapy agents (usually minimal thickness of 0.10 mm, minimal length of 270 mm).  
21  Gloves for use with chemotherapy agents should also undergo the standard biocompatibility 
testing for medical gloves. 
 
To market the glove for use in the handling and/or preparation of chemotherapeutic drugs, 
you should label the glove as a Patient Examination Glove or Surgeons Glove and 
Tested for use with [name of chemotherapeutic drug(s)].  
 
We recommend that you include the following labeling information (to enable the user to 
make an appropriate product selection): 
 
  chemical resistance data (test method used, chemicals tested), for consumer review, if 
desired,   
 
  the statement, Gloves used for protection against chemotherapy drug exposure should be 
selected specifically for the type of chemicals used, and 
 
  instructions for users to review drug labeling or material safety data sheets for the 
chemicals being used to determine an adequate level of protection for the intended use. 
   
Pyrogen/Endotoxin Labeling Claim 
 
FDA may consider a non-pyrogenic claim on a case-by-case basis for surgeons gloves.  The 
510(k) submission should contain data to support the claim.  In addition, the Quality System 
regulation includes requirements for, but not limited to, design controls, process validation, 
and process controls (21 CFR part 820).  If you label your  glove as non-pyrogenic, you 
should design the glove and validate the manufacturing process from the onset of 
manufacture to the finished packaged device.  You should continuously monitor the 
bioburden throughout the entire process to assure the bioburden is within the validated 
specifications.  The bioburden monitoring should include the slurry tank for the glove 
powder used to lubricate the gloves, as well as any bacterial over-growth that may occur 
subsequent to powdering and prior to sterilization.  You should establish manufacturing 
timeframes to minimize growth at every stage of the process.   
 
Hypoallergenicity 
 
For medical gloves distributed after September 30, 1998, 21 CFR 801.437(h) states Devices 
that contain natural rubber that contacts humans...shall not contain the term hypoallergenic 
on their labeling.  This includes gloves that have received prior 510(k) marketing clearance 
with a claim of hypoallergenicity.  Hypoallergenic incorrectly implies that latex sensitive 
persons may use a product labeled as hypoallergenic safely.   
 
FDA strongly discourages the use of the term hypoallergenic because the term cannot be 
scientifically defined or quantified.  Because  there is virtually no way to rule out allergies to 
any substance, FDA strongly discourages using the term hypoallergenic regarding any 
medical device, whether the device contains natural rubber latex or not. 
 
22  FDA does not require a new 510(k) submission for labeling changes made to comply with 21 
CFR 801.437, provided that you do not make any other changes requiring a new 510(k) 
submission.  However, you should keep appropriate records documenting the labeling 
changes. 
 
STANDARDS  
 
For voluntary labeling claims, you may state in the labeling that the product meets specific 
national or international consensus standard(s).  The labeling should clearly identify the 
standard by name or alphanumeric text, including the year published or other information to 
identify the specific standard.  If you make a voluntary claim, it should be truthful and 
accurate.  Note that a 510(k) submission may contain a declaration of conformity with any or 
all parts of a standard without an associated claim in the labeling. 
 
If the label states that a product meets a specific standard, the product delivered to the 
customer should meet the standard.  The manufacturer should have data on file to support 
these claims. 
 
LOT NUMBER  
 
Although FDA does not require a lot number to be placed on glove packaging, it is industry 
practice  for the package of medical gloves to bear a lot number.  Lot numbers are useful for 
traceability for complaints or returned product.  This number or code may identify the batch 
of compounded latex, the production lines, the production shift, and/or, if sterile, the 
sterilization run.  Some international consensus standards require lot numbers for 
conformance.  Gloves conforming to those standards should have lot numbers.  The lot 
number should be visible on the outside of the immediate packaging. 
 
BAR CODING 
 
Many manufacturers have started placing bar codes on cartons and on the bottom of 
dispenser boxes.  FDA encourages the use of bar coding. 
 
23  EXAMPLE LABELING  
The following are examples and do not represent real products: 
 
Example:  Powdered Latex Patient Examination Glove Box, Top  
 
 
ABC BRAND
 
POWDERED LATEX EXAMINATION GLOVES
 
Powdered with absorbable dusting powder, U.S.P. 
 
Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.   
 
Single Use Only 
Nonsterile 
     
     
 
 
 
 
 
Distributed by:                                                      CONTENTS: 100 Gloves (by weight) 
ABC Corporation                                                  SIZE:  MEDIUM 
Boston, MA  10001                                                 
Lot # 03C2004 
 
 
 
Example:  Powdered Latex Patient Examination Glove Box, Side 
 
 
ABC BRAND 
POWDERED LATEX EXAMINATION GLOVES 
CONTENTS: 100 Gloves (by weight)                                                           SIZE:  MEDIUM  
Powdered with absorbable dusting powder, U.S.P. 
Single Use Only 
 
 
 
Distributed by: 
ABC Corporation                                                                               
Boston, MA 10001  Product of Malaysia                       Lot: 03C2004 
 
 
24  Example:  Powder-Free Latex Patient Examination Glove Box, Top  
 
 
 

ABC  BRAND
 
POWDER-FREE LATEX EXAMINATION GLOVES
 
Lubricated with Silicone 
 
Single Use Only 
 
Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.   
 
     
   
 
 
 
 
 
Manufactured For:                                                    CONTENTS: 100 Gloves (by weight) 
DSMICARES Inc.                                                     SIZE:  MEDIUM 
Rockville, MD  20850 USA                                                                                 
 
 
 
 
Example:  Powder-Free Patient Examination Glove Box, Side (with voluntary expiration 
date and lot number) 
 
 
 

ABC  BRAND 
POWDER-FREE LATEX EXAMINATION GLOVES
 
 
Lubricated with Silicone 
Single Use Only 
CONTENTS:  100 Gloves (by weight) 
SIZE:  MEDIUM 
Manufactured For: 
DSMICARES Inc.                                                                      Use Before: Dec.  2006 
Rockville, MD  20850 USA               Product of Thailand                 Lot: 051199 
 
25  Example:  Powdered Vinyl Patient Examination Glove Box, Top 
 

ABC  BRAND
 
POWDERED VINYL EXAMINATION GLOVES
 
Powdered with absorbable dusting powder, U.S.P. 
Single Use Only 
 
 
     
   
 
 
 
 
CONTENTS: 100 Gloves (by weight) 
SIZE:  MEDIUM 
 
Manufactured For: 
Medical Art, Inc. 
Terrell, MD  28888 USA 
 
 
Example:  Powdered Vinyl Patient Examination Glove Box, Side 
 
 

ABC  BRAND 
POWDERED VINYL EXAMINATION GLOVES 
CONTENTS: 100 Gloves (by weight)                                                         SIZE:  MEDIUM  
 
Single Use Only 
Powdered with absorbable dusting powder, U.S.P. 
 
Manufactured For: 
Medical Art, Inc.                                                                           
Terrell, MD  28888  USA               Product of Taiwan                  Lot: 031100  
 
26   
Example:  Powdered Surgical Glove Unit Package 
 
 
   PEEL DOWN TO OPEN    
 

ABC  BRAND 
 
STERILE 
 
POWDERED LATEX 
SURGICAL GLOVES
 
Single Use Only 
Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.   
 
CONTENTS:  One Pair (2 Gloves) 
 
SIZE: 7 
 
Powdered with absorbable dusting powder 
 
Do NOT use if packaging is damaged. 
 
Lot:  S101000                                                              Use Before:  November 2006 
 
Distributed by: 
ABC Corporation                                                                              
Big Apple, NY 10018                                                     Product of Indonesia 
 
 
27  5  PREMARKET NOTIFICATION 510(K)  
 
TYPES OF 510(k) SUBMISSIONS .................................................................................... 28 
510(k) FEE .......................................................................................................................... 29 
INDICATIONS FOR USE STATEMENT ......................................................................... 29 
LABELING ......................................................................................................................... 30 
POWDER FOR EXAMINATION GLOVES ..................................................................... 30 
POWDER FOR SURGEONS GLOVES ........................................................................... 30 
COATINGS ......................................................................................................................... 31 
STERILITY ......................................................................................................................... 31 
510(k) SUMMARY OR STATEMENT .............................................................................. 31 
PRODUCT MODIFICATIONS .......................................................................................... 32 
TRANSFER OF OWNERSHIP OF A 510(k) ..................................................................... 33 
 
INTRODUCTION 
 
A Premarket Notification (510(k)) is a submission of information sent to the FDA to obtain 
marketing clearance for a medical device.  A 510(k) submission is a comparison of a new 
device with a predicate device.  A predicate device is a legally marketed device to which 
equivalence is established.  The 510(k) documents that the new finished medical glove you 
wish to market is as safe and effective as a legally marketed medical glove in the U.S. You 
cannot market medical gloves in the U.S. until you receive a letter from FDA declaring the 
gloves substantially equivalent (21 CFR 807.100(a)(5)).   
 
ASTM International (ASTM) has developed a number of medical glove related standards.  
CDRH has officially recognized many of these standards for premarket clearance purposes.  
Conformance to these standards is voluntary.  (See Chapter 10 of this guidance for more 
information on voluntary standards.) 
 
You should provide physical parameter and biocompatibility data obtained from tests and 
inspection of packaged and sterilized gloves (finished gloves).  The 510(k) submitter should 
keep this documentation on file.   
 
You can find detailed instructions for a 510(k) submission for patient examination gloves and 
surgeons gloves in Chapters 6 and 7, respectively.   
 
TYPES OF 510(k) SUBMISSIONS 
 
A 510(k) submitter may choose from three types of Premarket Notification 510(k) 
submissions for marketing clearance:  Traditional, Special, and Abbreviated.  The  
traditional 510(k) method is the original submission as provided in 21 CFR part 807.  There 
are two optional alternatives to the Traditional 510(k) method for obtaining 510(k) marketing 
clearance under certain instances:  Special 510(k) and Abbreviated 510(k).  The Special 
28  510(k) Device Modification utilizes certain aspects of the Quality System regulation to 
streamline 510(k) review; the Abbreviated 510(k) relies on the use of guidance documents, 
special controls (for class II devices), and recognized standards to facilitate 510(k) review.  
Additional information about the 510(k) submission process is available at 
http://www.fda.gov/cdrh/devadvice/314.html.  
 
510(k) FEE 
 
As of October 1, 2002, FDA charges a fee to review 510(k) submissions.  This submission 
fee applies to Traditional, Abbreviated, and Special 510(k)s.  FDA should receive payment 
on or before the time you submit the 510(k) submission.  If the submitter has not paid all fees 
owed, FDA will consider the submission incomplete and will not accept it for filing.  You 
should direct questions regarding user fees to the Division of Small Manufacturers, 
International and Consumer Assistance at 240-276-3150. 
 
Additional information, including the current review fee for a 510(k), is available at 
http://www.fda.gov/cdrh/devadvice/314a.html.  
 
INDICATIONS FOR USE STATEMENT  
 
For medical gloves, the indication for use is the same as the intended use.  The information, 
data, and labeling claims in the entire 510(k) submission should support and agree with the 
Indications for Use statement.  CDRH will attach the Indications for Use statement to the 
substantial equivalence letter that is sent to the submitter when the 510(k) is cleared. 
 
We recommend one of the following statements or equivalent text as an indication for use 
statement. 
 
Powdered Examination Gloves  
A powdered patient examination glove is a disposable device intended for medical 
purposes that is worn on the examiner's hand or finger to prevent contamination 
between patient and examiner. 
 
Powder-Free Examination Gloves 
A powder-free patient examination glove is a disposable device intended for medical 
purposes that is worn on the examiner's hand or finger to prevent contamination 
between patient and examiner. 
 
Powdered surgeon's gloves 
A powdered surgeon's glove is a device made of natural or synthetic rubber intended 
to be worn by operating room personnel to protect a surgical wound from 
contamination.  
 
29  Powder-free surgeon's gloves 
A powder-free surgeon's glove is a device made of natural or synthetic rubber 
intended to be worn by operating room personnel to protect a surgical wound from 
contamination.  
 
For a special purpose glove, you should include additional text in the Indications for Use 
statement that covers the additional function of the glove as stated in your labeling.  You 
should also indicate that it is an over-the-counter device. 
 
LABELING 
 
Medical glove 510(k) submissions should include samples of the package labeling.  Labeling 
does not need to be in final printed format; you may submit draft labeling.  The final labeling 
should be consistent with the draft labeling you submitted in the 510(k).  The final labeling 
should agree with your drawings for labeling and preprinted packaging in your Quality 
System device master record (21 CFR 820.181), and comply with other applicable 
requirements in the Act and regulations.   
 
Labeling, labeling claims, and data should be consistent with the Indications for Use 
statement.  If you make any specific claims for your gloves, you should include data to 
substantiate the claims in this format or in identified attachments.  Puffery, ambiguous, or 
unsubstantiated claims such as super strong, extra thick, micro thin, super sensitive, or low 
protein, are not appropriate.   
 
POWDER FOR EXAMINATION GLOVES 
 
Powder used for lubricating examination gloves should meet the United States 
Pharmacopoeia (U.S.P.) monograph for absorbable dusting powder or be equivalent in terms 
of safety and effectiveness.  The 510(k) should include the type, specifications, and source of 
powder or other donning lubricant used on the gloves.  You should not use talc, cotton flock, 
and other non-absorbable materials as a lubricating, dusting, or donning powder.  
Lycopodium (club moss spores) and ground pine pollen are toxic and are not acceptable as 
powder on or in medical gloves.   
 
POWDER FOR SURGEONS GLOVES 
 
Absorbable donning or dusting powder from powder manufacturers that have obtained an 
approved new drug application (NDA), abbreviated new drug application (ANDA), or 
premarket approval application (PMA) must be used on powdered surgeons gloves (21 CFR 
878.4480).  A list of firms with approved NDAs or PMAs for Surgical Dusting Powder is 
available at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm.  Use Product 
Code KGP as the search term. 
 
30  COATINGS 
 
Premarket Notification 510(k) submissions for coated medical gloves should contain 
complete information about the composition and intended purpose of the coating used, e.g., 
ease of donning.  The draft labeling should also contain any special or additional claims for 
the gloves due to the presence of the coating, e.g., easier to don. 
 
STERILITY 
 
For gloves that are labeled as sterile, FDA recommends that you provide sterilization 
information in accordance with Updated 510(k) Sterility Review Guidance K90-1 available 
at  http://www.fda.gov/cdrh/ode/guidance/361.html.  You should sterilize the gloves to a 
sterility assurance level (SAL) of 1 x 10-6 using a sterilization cycle that has been validated in 
accordance with the Quality Systems requirements, 21 CFR part 820. 
 
510(k) SUMMARY OR STATEMENT 
 
In accordance with 21 CFR 807.87(h), the Premarket Notification 510(k) submission must 
include either a 510(k) Summary or a 510(k) Statement:  
 
510(k) Summary is a summary of the 510(k) in sufficient detail to provide an 
understanding of the basis for a determination of substantial equivalence (21 CFR 
807.92). 
 
510(k) Statement is a certification that the 510(k) holder will provide a copy of the entire 
510(k) submission, excluding patient identifiers, trade secret, and confidential 
commercial information, to any person within 30 days of a written request (21 CFR 
807.93).  You may not charge requesters for a copy of the 510(k) submission..  
 
You should make the choice between the 510(k) Summary and 510(k) Statement before you 
submit the 510(k).  You may elect to change your choice between the summary or statement 
before FDA determines substantial equivalence.  FDA will accept Summaries or amendments 
to Summaries until FDA issues a determination of substantial equivalence.  After the 
determination, you cannot modify the 510(k) Summary or change your choice of a 510(k) 
Summary or 510(k) Statement.  See 21 CFR 807.92(a). 
Further information regarding the content of the 510(k) Summary or 510(k) Statement may 
be obtained at www.fda.gov/cdrh/devadvice/314312.html#link_7.   
510(k) Summary 
 
We provide the following supplemental information for 510(k) Summaries for medical 
gloves. 
 
31  21 CFR 807.92(a)(2) 
Examples: 
Trade name - ABC Latex Examination Gloves 
Common name - exam gloves 
Classification name - patient examination glove 
 
21 CFR 807.92(a)(4) 
You should describe any variations from the predicate device.  For special purpose 
gloves, describe the special features.   
 
21 CFR 807.92(a)(6) 
We recommend that you include a brief table of the measured parameters of your 
finished gloves compared to FDA-recognized consensus standards or equivalent 
methods.  You should include data that show conformance with FDA 
biocompatibility, pinhole, powder residual and other specifications and 
recommendations and any other parameter for which you have a labeling claim. 
 
21 CFR 807.92(b)(2)   
Clinical data is usually not needed for medical glove 510(k) submissions. 
 
21 CFR 807.92(b)(3) 
We recommend that you state that your gloves meet the FDA-recognized consensus 
standard or equivalent method and meet your labeling claims and pinhole acceptable 
quality level (AQL) as shown by the data in 21 CFR 807.92(a)(6).   
 
   
510(k) Statement  
 
The statement should be on a separate letterhead page, clearly identified as 510(k) 
statement, signed by the certifier, not a consultant to the 510(k) submitter, and should 
include the specific language provided in 21 CFR 807.93. 
 
Premarket Notification 510(k) Statement 
http://www.fda.gov/cdrh/manual/stmnt2.html  
 
PRODUCT MODIFICATIONS 
 
If you make a change to your gloves that significantly affects safety or effectiveness of the 
gloves, you must submit a new and complete 510(k) (21 CFR 807.81(a)(3)).  Examples of 
changes that may require a new 510(k) include adding or deleting powder; adding color, 
fragrance, or a claim to the labeling; or modifying an important process.  FDA usually does 
not require a new 510(k) if a manufacturer only does more of an existing process, such as 
extra leaching or washing, and makes no claim or mention of this change on the product 
labeling.   
 
32  Changes to patient examination gloves, labeling, packaging, and processes should meet the 
Quality System regulation at 21 CFR 820.40 and 820.70(b).  You should make changes to 
surgeons gloves, labeling, packaging, and processes in accordance with Quality System 
regulation at 21 CFR 820.30, 820.40, and 820.70(b).  If you do not need a new 510(k), you 
should document your decision and how you arrived at it in the device master record (21 
CFR 820.181).   
 
We recommend the following guidance document for additional information:  
 
Deciding When to Submit a 510(k) for a Change to an Existing Device  
http://www.fda.gov/cdrh/ode/510kmod.html 
 
You may submit a Special 510(k) submission for a modification to an existing glove 
510(k) held by the same submitter. 
 
TRANSFER OF OWNERSHIP OF A 510(k) 
 
A 510(k) may be bought, sold, or transferred.  FDA is not involved in transfers of ownership.  
The new owner should maintain information documenting the transfer of ownership of a 
510(k), including any legal transactions that took place, in its 510(k) files. 
 
The new owner should list the device according to 21 CFR part 807 and the previous owner 
should delete its device listing.  Upon inspection of the firm or upon entry of glove shipments 
into the U.S., FDA may request a review of documentation of ownership.  If the owner is not 
able to provide the information, FDA may request the owner to submit a 510(k).  You may 
not distribute the gloves until FDA clears the new submission. 
 
Note that neither a registration nor a listing  proves 510(k) ownership.  The new owner of the 
510(k) should maintain files with documentation proving ownership of the 510(k). 
 
To avoid problems when importing a device with a transferred 510(k) ownership, FDA 
recommends that a copy of the specific information relating to the ownership sale or transfer 
accompany all shipments to the United States.  This could be a simple one-page document 
detailing the transfer transaction. 
 
33  6  PATIENT EXAMINATION GLOVES 
 
POWDER-FREE ................................................................................................................. 34 
CHEMOTHERAPY GLOVES............................................................................................ 34 
FORMAT FOR PREMARKET NOTIFICATION 510(k) .................................................. 35 
 
POWDER-FREE 
 
To substantiate a powder-free claim in your Premarket Notification (510(k)) submission, 
you should state whether the manufacturing process for the glove includes any powder, such 
as a former-release powder and/or a donning powder.  If it does, you should provide: 
 
1.  a description of the powder(s) introduced at any stage of the glove manufacturing 
process, such as former release or stripping powder and donning powder; 
 
2.  a detailed description of the process to remove the added powder(s); 
 
3.  a description of the release specification supporting the powder-free claim and a brief 
summary of the final product testing to ensure the glove meets this specification; 
 
4.  a description of how the glove is designed or manufactured to compensate for the lack 
of donning powder, or reasons why the compensation is not necessary, including a 
full characterization such as the chemical identity, specifications, and 
biocompatibility of any material such as silicone added to the glove to facilitate glove 
donning; and 
 
5.  a certification that the finished powder-free glove meets ASTM International (ASTM) 
standard D3577 (Standard Specification for Rubber Surgical Gloves), D3578 
(Standard Specification for Rubber Examination Gloves), D5250 (Standard 
Specification for Poly(vinyl chloride) Gloves for Medical Application), or an 
equivalent standard, as appropriate. 
 
If the entire manufacturing process does not include any former release or donning powder, 
then you only need to discuss items 4 and 5 in the above list. 
 
CHEMOTHERAPY GLOVES 
 
Chemotherapy gloves are specialty medical gloves.  We recommend that you use the 510(k) 
format for chemotherapy gloves provided later in this chapter.  If you label patient 
examination gloves designed for handling chemotherapy agents as, Tested for Use with 
Chemotherapy Agents," you should provide data to support the claim.  Otherwise, labeling, 
donning powder or lubricant, protein, and powder-free specifications for chemotherapy 
gloves are the same as for examination gloves. 
34   
You should include in the 510(k) submission the results of a controlled scientific study 
completed on the finished device to substantiate the claim.  Test data should show the gloves 
are chemically resistant and/or can resist the permeation of chemical agents.  Chemical 
resistance includes resistance of the glove to swelling, degradation, or deformation.  The test 
method for permeability determines the time for a hazardous liquid (including temperature 
and concentration, if necessary) to permeate the barrier membrane of the glove as well as the 
rate of penetration once the barrier has been breached.  
 
Testing should utilize the actual chemicals to be encountered, using the finished product, 
under the expected in use conditions (i.e., length of exposure, chemical concentration, 
contact, and temperature).  Supporting test data should include an explanation and/or method 
of selecting the chemicals tested, a comprehensive description of the test method used, the 
complete protocol, an analysis of test results, a discussion, and the conclusions.   
 
Chemotherapy gloves should meet an appropriate ASTM standard or an equivalent 
consensus standard for medical gloves.  Physical features, such as increased thickness and 
length, make them more suitable for the safe handling of chemotherapy agents (usually 
minimal thickness of 0.10 mm, minimal length of 270 mm).   
 
Premarket Notification (510(k)) submissions for Chemotherapy gloves should contain: 
 
  the product labeling that specifies the chemical(s) that the glove provide(s) protection 
against; 
  the results of a controlled scientific study to substantiate the claim, 
  a comprehensive description of the test method used,  
  the complete test protocol, 
  an analysis of test results,  
  a discussion as appropriate, and  
  conclusions. 
 
Chemotherapy gloves should also undergo standard biocompatibility testing for medical 
gloves. 
 
FORMAT FOR PREMARKET NOTIFICATION 510(k) 
 
This section contains a suggested format for the submission of a Premarket Notification 
(510(k)) for patient examination gloves.  FDA does not require this format, but you may use 
it as a guide for submitting the necessary information to FDA.  The suggested format should 
increase the completeness and accuracy of your submission and may reduce the time needed 
for review of your submission.   
 
Although a single 510(k) submission for colored, flavored, or scented gloves may include 
more than one color and/or flavor or scent, you should test each glove type separately, as a 
35  finished glove, for biocompatibility and all physical characteristics.  Data for multiple types 
of gloves should be in separate attachments. 
 
A 510(k) submission should be complete; that is, you should not reference information from 
a previous 510(k) submission.  
 
We recommend that you  identify all attachments with the topic and the submitters name, 
street address, phone, and fax numbers.  You should number the pages in your submission 
and attachments and include a table of contents.  Do not include unnecessary information 
such as copies of standards and details of test equipment.   
 
Sample Format for a Premarket Notification 510(k) for Examination Gloves 
We recommend that you follow the Abbreviated 510(k) format provided in the guidance 
document, "Format for Traditional and Abbreviated 510(k)s" available at 
http://www.fda.gov/cdrh/ode/guidance/1567.html  The guidance document will help you 
create a complete 510(k). Pertinent elements of a 510(k) are reiterated below and are 
described in the guidance.  
  Medical Device User Fee Cover Sheet (Form FDA 3601). See 510(k) Review Fees at 
http://www.fda.gov/cdrh/devadvice/314a.html for additional information.  
  CDRH Premarket Review Submission Cover Sheet available at  
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3514.pdf or 
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3514.doc   
  Cover letter as described in the format guidance  
  Table of Contents (recommended)  
  Indications for Use  available at 
http://www.fda.gov/cdrh/devadvice/314312.html#link_6  
  510(k) Summary (21 CFR 807.92) or 510(k) Statement (21 CFR 807.93). See 
Chapter 5 of this manual. 
  Truthful and Accuracy Statement (21 CFR 807.87(k)) available at 
http://www.fda.gov/cdrh/manual/stmnt2.html  
  Provide items required under 21 CFR 807.87 (Information required in a Premarket 
Notification submission).  We recommend the following format for a patient 
examination glove 510(k) submission. 
Executive Summary: 
We recommend you that you provide an executive summary of the 510(k), which should 
include a concise description of the device, including the indications for use and concise 
summary for any performance testing in the submission.  We recommend that you identify 
all variations (for example, various colors) of gloves covered in the 510(k) submission.  If 
this submission is for a modification of a patient examination glove cleared by FDA for 
marketing, include the 510(k) number of the cleared glove. 
36  Classification Information: 
Device Class:  Class I 
Device Name:  Patient examination gloves - 21 CFR 880.6250 
 
Product Code 
  
 [ ] Latex - LYY    [ ] Nitrile - LZA 
 [ ] Vinyl - LYZ     [ ] Specialty - LZC  
 [ ] Synthetic Polymer - LZA    [ ] Finger Cot - LZB 
 
If  the glove is made of a polymer or other type of material. identify the material.  
_________________________________________________ 
 
Device Description and Specifications (of your specific Latex or Synthetic "xxxx" Polymer 
Glove):  
      Overall Length:________mm minimum 
      Width: ________mm minimum (for medium glove) 
      Palm Thickness:________mm minimum  
      Finger Thickness: ________mm minimum  
      Tensile Strength:  
before aging _____________ Mpa minimum  
after aging _______________Mpa minimum 
      Ultimate Elongation: 
before aging _____________% minimum 
after aging ______________ % minimum 
      Pinhole AQL:  ____________ 
 
If latex gloves:   
Does the above data for your examination gloves meet all the current specifications listed 
under the ASTM standard D3578 or an equivalent consensus standard? 
 
YES ___ NO ___    If NO, explain why in an identified attachment.   
 
If vinyl:    
Do the vinyl examination gloves meet all the current specifications listed under ASTM 
Specification D5250 or an equivalent consensus standard?  
 
YES ___ NO ___    If NO, explain why in an identified attachment. 
 
If synthetic polymer gloves:  
Does the above data for your synthetic/polychloroprene examination glove meet all the 
current specifications listed under the applicable ASTM standard D3578, D6977, or a 
standard for gloves composed of the specific synthetic polymer/nitrile glove? 
 
YES ___ NO ___    If NO, explain why in an identified attachment. 
37   
 
If nitrile gloves:  
Does the above data for your nitrile examination glove meet all the current specifications 
listed under the applicable ASTM standard D6319 or an equivalent consensus standard? 
 
YES ___ NO ___    If NO, explain why in an identified attachment. 
 
Specialty, Chemotherapy Gloves:  
For chemotherapy or other specialty gloves, include data in an identified attachment to 
demonstrate the gloves are safe and effective to support labeling claims.  (See Chapter 4 for 
guidance on labeling of medical gloves intended for use with chemotherapy agents.) 
 
Former Release Powder or Chemical:  
(If none is used, state that no release powder or chemical is used.) 
 
Release Powder  
or Chemical: _____________________________________________________ 
 
Supplier :  _______________________________________________________ 
 
Specifications: ____________________________________________________ 
 
 
Dusting or Donning Powder:  
(If none, state "powder-free") 
 
Note:  ASTM standards do not allow talc on the surface of medical gloves.  Lycopodium 
(club moss spores) and ground pine pollen are toxic and are not acceptable as powder on or 
in medical gloves. 
 
U.S.P.  Absorbable Dusting Powder used?  
YES _____ NO _____ 
   
If non-U.S.P. absorbable dusting powder is used, provide the following: 
 
Powder Type:  ____________________________________________________ 
 
Supplier:_________________________________________________________ 
 
Brand Name:_____________________________________________________ 
 
Specifications:  ___________________________________________________ 
 
38  Weight of Donning Powder: 
Weight of all types of powder on finished powder glove _____ +/- ____ milligrams per dm2.  
Powder should be measured by ASTM D6124 or an equivalent test method. 
 
Weight of Residual or Trace Powder Residue on Powder-free Gloves: 
Weight of all types of residual or trace powder on finished powder-free glove _____ +/- 
_____ mg per glove determined by ASTM D6124.  The weight of trace powder should not 
exceed 2 mg per glove or the limit in the ASTM standard. 
 
If the gloves are powder-free, and the process includes any mold/former release or donning 
powder, we recommend that you provide the following: 
 
Describe the powder(s) introduced at any stage of the glove manufacturing process. 
 
In an identified attachment, describe in detail the process to remove the added powder(s). 
 
In an identified attachment, include and describe the finished glove release specification 
supporting the "powder-free" claim and a brief summary of final product testing to ensure 
finished gloves meet this specification.  (You should use the ASTM D6124 method or an 
equivalent method for measuring residual or trace powder.) 
 
If the gloves are powder-free and the manufacturing process does NOT include any powder, 
we recommend that you provide the following. 
 
Describe in an identified attachment how the glove is designed or manufactured to 
compensate for the lack of donning powder, or reasons why compensation is not necessary, 
including a full chemical characterization (e.g., chemical identity, specifications, 
biocompatibility) of any material used to facilitate glove donning, such as silicone or 
polymer coating on the glove.  If a donning lubricant is used, state the composition and 
include biocompatibility data for the lubricant in an identified attachment; also state the 
name, manufacturer, and address below: 
 
Lubricant  
Generic Name:  _____________________________________________________ 
 
Lubricant  
Brand Name(s):  _____________________________________________________ 
Chemical Name:    ___________________________________________________ 
 
Lubricant  
Manufacturer:  _______________________________________________________ 
 
Address:  ___________________________________________________________ 
    ___________________________________________________________ 
 
39  We recommend you certify that your finished "powder-free" gloves meet the following: 
  ASTM D3578 standard or equivalent standard for natural rubber latex, 
  ASTM D 5250 standard or an equivalent standard for vinyl, or 
  ASTM D6319 standard or an equivalent standard for nitrile.  
 
Protein Level of Natural Rubber Latex Gloves: 
Protein level as measured by a standard method recognized by FDA _________________ 
mcg/dm2.   
 
Was a Standard Test Method used to determine the protein level?  
 
YES _____ NO_____ 
 
Specify the Standard Test Method used,  
including the year  _____________________ 
 
If no, include a complete description of the test method used and data showing how it 
correlates with a recognized standard method.  You may check the CDRH website for a list 
of currently recognized standard test methods.  The searchable standards database is 
available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 
 
The protein testing was performed on the finished gloves that have undergone real time aging 
or accelerated aging per ASTM D3578:  
 
YES _____ NO _____ 
 
We recommend that you include a summary of test results from samples of at least one lot of 
gloves that supports your stated protein level. 
 
Protein Control: 
We recommend that you specify what test will be used for determining protein content 
during routine production: ____________________.   
 
If this is not a Standard Test method, please provide data correlating the routine quality 
control method to a recognized standard test method.  
 
Chemical Sensitivity Claim: 
If your labeling makes claims regarding the reduced potential of chemical sensitization or 
reduced reaction-inducing potential of your gloves in allergic individuals, you should provide 
supporting data in an identified attachment.  We recommend the attachment present a 
summary of the data from appropriate testing.   
 
Other Claims:  
List any other claims that need supporting data and provide the data. 
 
40  List in a table format the appropriate assay and timeframe for the evaluation that you used for 
each of the claims. 
 
Color, Scent or Flavor Additives:  
You should identify any color, scent, or flavor additive used in manufacturing medical 
gloves.  You should provide the chemical name and composition of the color, scent, or flavor 
additive used and include biocompatibility data to support safe use of the additive. 
 
Labels, Labeling, and Advertising:  
The proposed labeling should include basic information (21 CFR 801) and appropriate 
caution statements. We recommend that you include identified copies of all labeling or 
proposed labeling, including promotional literature.   
 
Sterility:  
Are these examination gloves labeled as sterile?  
 
YES _____ NO _____  
 
If YES, state sterilization method (radiation, gas, etc.) used:  
________________________________________ 
 
Sterility Assurance Level (SAL): ______________________________________ 
 
The SAL is the statistical probability of a glove not being sterile after going through the 
validated sterilization cycle.  The SAL should be 10-6 or better for a sterile glove. 
 
Provide the method used to validate the sterilization cycle.  Validation data is not required to 
be submitted in the 510(k). 
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________ 
 
If Radiation sterilization, dose in Kilograys ________________  
 
If EtO Sterilization, reference the methods for determining residues and state the level of 
residue in parts per million (PPM):  
 
Test Methods _________________________________ 
Ethylene Oxide ________________________________ 
Ethylene Chlorohydrin __________________________ 
 
41  Describe packaging used to maintain sterility:  
___________________________________________________________________________
___________________________________________________________________________
______________________________________________________ 
 
Sterilizer: 
Name_____________________________________________________________ 
Street Address___________________________________________________________ 
Country___________________________________________________________ 
 
Phone No.  ________________________  Fax No.  _______________________ 
 
Registration Number of Sterilizer:  _____________________________________ 
 
If sterilization is done by a contractor, the glove manufacturer should have a contract 
with the contract sterilizer that meets the specifications of 21 CFR 801.150(e).  An 
importer may need two written agreements: one with the foreign manufacturer and a 
second agreement with the contract sterilizer. 
 
Expiration Date:  
If you want to include an expiration date on the labeling of the gloves covered by this 510(k) 
submission, specify the length of the expiration period in months and years for which you 
have valid supporting data.  You should maintain data that supports expiration dating of the 
gloves.   
 
Biocompatibility:   
You should evaluate the biocompatibility of finished gloves and submit the result in an 
identified attachment.  You should cite the specific test methods used and state the results 
obtained, i.e., under conditions of the tests, the finished sterile gloves were not (or were) 
sensitizing and were not (or were) irritating.  
Please refer to 510(k) Format Tips available at 
http://www.fda.gov/cdrh/devadvice/314311.html for additional tips on the format of a 510(k) 
submission.  
 
42  7  SURGEONS GLOVES 
 
POWDER-FREE ................................................................................................................. 43 
FORMAT FOR PREMARKET NOTIFICATION 510(k) .................................................. 43 
 
POWDER-FREE 
 
Powder-free surgeons gloves may be lubricated with small amounts of silicone or other 
suitable lubricant or be coated with a non-tacky polymer.  A Premarket Notification (510(k)) 
submission should include a full characterization of the lubricant or coating such as the 
chemical identity, specifications, and biocompatibility. 
 
FORMAT FOR PREMARKET NOTIFICATION 510(k) 
 
This section contains a suggested format for the submission of a Premarket Notification 
(510(k)) for surgeons gloves.  FDA does not require this format; however, you may use it as 
a guide for submitting the information to FDA.  This format should increase the 
completeness and accuracy of your submission and reduce the time needed for review of 
your submission.   
 
Although a single 510(k) submission for colored, flavored, or scented gloves may include 
more than one color and/or flavor or scent, you should test each glove type separately as a 
finished glove, for biocompatibility and all physical characteristics.  Data for multiple types 
of gloves should be in separate attachments. 
 
The person having direct or contractual control over sterilization should submit the 510(k) 
for surgeons gloves.  If the manufacturer does the sterilization or contracts for the 
sterilization, the manufacturer submits the 510(k).  For imported prelabeled sterile but not-
yet-sterilized surgeons gloves, the importer that contracts for the sterilization should submit 
the 510(k) to FDA.  However, the submitter should identify the manufacturer of the gloves in 
the submission.   
 
A 510(k) submission should be complete; that is, you should not reference information from 
a previous 510(k) submission.  
 
We recommend that you identify all attachments with the topic and the submitters name, 
street address, phone, and fax numbers.  You should number the pages in your submission 
and attachments and include a table of contents.  Do not include extraneous information such 
as copies of standards and details of test equipment.   
 
43  Sample Format for a Premarket Notification (510(k)) for Surgeons Gloves 
We recommend that you follow the Abbreviated 510(k) format provided in the guidance 
document, "Format for Traditional and Abbreviated 510(k)s" available at 
http://www.fda.gov/cdrh/ode/guidance/1567.html  The guidance document will help you 
create a complete 510(k). Pertinent elements of a 510(k) are reiterated below and are 
described in the guidance.  
  Medical Device User Fee Cover Sheet (Form FDA 3601). See 510(k) Review Fees at 
http://www.fda.gov/cdrh/devadvice/314a.html for additional information.  
  CDRH Premarket Review Submission Cover Sheet available at  
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3514.pdf or 
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3514.doc   
  Cover letter as described in the format guidance  
  Table of Contents (recommended)  
  Indications for Use  available at 
http://www.fda.gov/cdrh/devadvice/314312.html#link_6  
  510(k) Summary (21 CFR 807.92) or 510(k) Statement (21 CFR 807.93). See 
Chapter 5 of this manual. 
  Truthful and Accuracy Statement (21 CFR 807.87(k)) available at 
http://www.fda.gov/cdrh/manual/stmnt2.html  
  Provide items required under 21 CFR 807.87 (Information required in a Premarket 
Notification submission).  We recommend the following format for a patient 
examination glove 510(k) submission. 
 
Executive Summary: 
We recommend you that you provide an executive summary of the 510(k), which should 
include a concise description of the device, including the indications for use and concise 
summary for any performance testing in the submission.  We recommend that you identify 
all variations (for example, various colors) of gloves covered in the 510(k) submission. If this 
submission is for a modification of a surgeons glove cleared by FDA for marketing, include 
the 510(k) number of the cleared glove.  
 
Classification Information: 
Device Class:  Class I 
Device Description of Substantially Equivalent Device:  
Surgeons gloves - 21 CFR 878.4460 
 
Type:  (check one)  
[  ]  Type 1 - gloves compounded primarily from natural rubber latex, or 
[  ]  Type 2 - gloves compounded primarily from rubber cement or synthetic rubber 
latex. 
 
44  Product Code:  ( check one ) 
[  ] Surgeons Glove - 79KGO 
[  ] Glove Liners  - 79KGO 
[  ] Autopsy Gloves  79KGO 
 
Composition of Gloves:   ( check one) 
[  ] Latex  [  ] Latex Polymer Coated 
[  ] Synthetic Polymer   [  ] Co-Polymer 
[  ] Other, specify polymer(s) below, including any amount of natural rubber latex: 
 
Describe polymer or other:    
 
Device Description and Specifications: 
Overall Length:    ________ mm minimum 
Width:  ________ mm minimum (for medium glove) 
Palm Thickness:  ________ mm minimum 
Finger Thickness:   ________ mm minimum 
Tensile Strength:  
before aging _____________ Mpa minimum  
after aging _______________Mpa minimum 
Ultimate Elongation: 
before aging _____________% minimum 
after aging ______________ % minimum 
Pinhole AQL:  ____________ 
 
If latex gloves:  
Does the above data for your latex surgeons gloves meet all the current specifications listed 
in the ASTM standard D3577 or an equivalent consensus standard? 
 
YES ____   NO ____    
 
If NO, explain why in an identified attachment and state the equivalent standard to 
which your gloves conform.   
 
If synthetic polymer gloves:  
Does the above data for your polymer surgeons gloves meet all the current specifications 
listed under ASTM standard D3577 or an equivalent standard for gloves composed of the 
specific synthetic polymer? 
 
YES ____   NO ____    
 
If NO, state the glove composition and all of your specifications in an identified 
attachment; and state the equivalent standard to which your gloves conform. 
 
45  Specialty Surgeons Gloves: 
If the submission contains a special claim, include data in an identified attachment to show 
that the specialty surgeons gloves are safe and effective for the special claim. 
 
Former Release Powder or Chemical:  
(If none is used, state that no release powder or chemical is used.) 
 
Release Powder  
or Chemical: _____________________________________________________ 
 
Supplier :  _______________________________________________________ 
 
Specifications: ____________________________________________________ 
 
Absorbable Dusting or Donning Powder:   
(If none, state powder-free.)  
 
Note:  ASTM standards do not allow Talc on the surface of medical gloves.   
 
NDA, ANDA or PMA number:  ______________________________________ 
 
Supplier:_________________________________________________________ 
 
Address:_________________________________________________________ 
 
Brand Name:_____________________________________________________ 
 
Specifications:  ___________________________________________________ 
 
For Finished Powdered Gloves:  
Weight of all types of powder on a glove _______ +/- _______ milligrams per dm2.  Powder 
should be measured by ASTM D6124 or an equivalent test method. 
 
Weight of Residual or Trace Powder Residue on Powder-free Gloves:  
Weight of all types of residual or trace powder on finished powder-free glove _____ +/- 
_____ mg per glove determined by ASTM D6124.  The weight of trace powder should not 
exceed 2 mg per glove or the limit in the ASTM standard. 
 
If the gloves are powder-free and the process includes any mold / former release or donning 
powder, then the applicant should provide items 13.1 through 13.5 below.  If the gloves are 
"powder-free" and the manufacturing process does NOT include any powder, then the 
applicant should complete items 13.4 and 13.5 below. 
 
Describe the powder(s) introduced at any stage of the glove manufacturing process. 
 
In an identified attachment, describe in detail the process to remove the added powder(s). 
46   
In an identified attachment, include and describe the finished glove release specification 
supporting the "powder-free" claim and a brief summary of final product testing to ensure 
finished gloves meet this specification.  (You should use the ASTM D6124 method or an 
equivalent method for measuring residual or trace powder.) 
 
Describe in an identified attachment how the glove is designed or manufactured to 
compensate for the lack of donning powder, or reasons why compensation is not necessary, 
including a full chemical characterization (e.g., chemical identity, specifications, 
biocompatibility) of any material used to facilitate glove donning, such as silicone or 
polymer coating on the glove.  If a donning lubricant is used, state the composition and 
include biocompatibility data for the lubricant in an identified attachment; also state the 
name, manufacturer, and address below: 
 
Lubricant  
Generic Name:  ______________________________________________________ 
 
Lubricant  
Brand Name(s):  _____________________________________________________ 
Chemical Name: _____________________________________________________ 
 
Lubricant  
Manufacturer:  _______________________________________________________ 
 
Address:  ___________________________________________________________ 
    ___________________________________________________________ 
 
We recommend that you should certify that your finished sterile powder-free gloves meet 
ASTM D3577 standard or an equivalent standard for latex and polymers.   
 
Protein Level of Natural Rubber Latex Gloves:   
State the protein level as measured by a standard method recognized by Center for Devices 
and Radiological Health (CDRH) _________________ mcg/dm2. 
 
Was a Standard Test Method used to determine the protein level?  
 
YES _____ NO_____ 
 
Specify the Standard Test Method used,  
including the year _____________________ 
 
If no, include a complete description of the test method used and data showing how it 
correlates with a recognized standard method.  You may check the CDRH website for a list 
of currently recognized standard test methods.  The searchable standards database is 
available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm  
 
47  The protein testing was performed on the finished gloves that have undergone real time aging 
or accelerated aging per ASTM D3577:  
 
YES _____ NO _____  
 
We recommend that you include a summary of test results from samples of at least one lot of 
gloves that supports your stated protein level. 
 
Protein Control:  
Specify what test will be used for determining protein content during routine production: 
____________________.   
 
If this is not a Standard Test method, include data correlating the routine quality control 
method to a recognized standard test method. 
 
Chemical Sensitivity Claim:  
If your labeling makes claims regarding the reduced potential of chemical sensitization or 
reduced reaction-inducing potential of your gloves in allergic individuals, you should provide 
supporting data in an identified attachment.  We recommend the attachment present a 
summary of the data from appropriate testing.   
 
Other Claims:  
List any other claims that need supporting data and provide the data. 
 
List in a table format the appropriate assay and timeframe for the evaluation that you used for 
each of the claims. 
 
Color, Scent, or Flavor Additives:  
You should identify any color, scent, or flavor additive used in manufacturing medical 
gloves.  You should provide the chemical name and composition of the color, scent, or flavor 
additive used and include biocompatibility data to support safe use of the additive. 
 
Labels, Labeling, and Advertising:  
The labeling should include basic information (21 CFR part 801) and appropriate caution 
statements.  We recommend that you include identified copies of all labeling or proposed 
labeling, including promotional literature.  If the gloves are powdered, labeling should 
include the statement, Powdered with Absorbable Dusting Powder. 
 
Sterility: 
State sterilization method (radiation, gas, etc.) used:   
 
Sterility Assurance Level (SAL):  ___________ 
 
The SAL is the statistical probability of a glove not being sterile after going through the 
validated sterilization cycle.  The SAL should be 10-6 or better for a sterile glove. 
 
48  Provide the method used to validate the sterilization cycle.  Validation data is not required to 
be submitted in the 510(k). 
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
________________________________________ 
 
If radiation sterilization, dose in Kilograys: ________________  
 
If EtO sterilization, reference the methods for determining residues and state the level of 
residue in parts per million (PPM):  
 
Test Methods  __________________________ 
Ethylene Oxide ________________________________ 
Ethylene Chlorohydrin __________________________ 
 
Describe packaging used to maintain sterility:  
___________________________________________________________________________
___________________________________________________________________________
______________________________________________________ 
 
Sterilizer: 
Name_____________________________________________________________ 
Street Address___________________________________________________________ 
Country___________________________________________________________ 
 
Phone No.  ________________________  Fax No.  _______________________ 
 
Registration Number of Sterilizer:  _____________________________________ 
 
If sterilization is done by a contractor, the glove manufacturer should have a contract 
with the contract sterilizer that meets the specifications of 21 CFR 801.150(e).  An 
importer may need two written agreements: one with the foreign manufacturer and a 
second agreement with the contract sterilizer. 
 
Expiration Date:  
If you want to include an expiration date on the labeling of the gloves covered by this 510(k) 
submission, specify the length of the expiration period in months and years for which you 
have valid supporting data.  Data should be maintained by the manufacturers to support 
expiration dating of their gloves.  (See Chapter 4 for labeling guidance.) 
 
Biocompatibility:   
You should evaluate the biocompatibility tests on finished gloves and submit the result in an 
identified attachment.  You should cite the specific test methods used and state the results 
49  obtained, i.e., under conditions of the tests, the finished sterile gloves were not (or were) 
sensitizing and were not (or were) irritating.  
 
Please refer to 510(k) Format Tips available at 
http://www.fda.gov/cdrh/devadvice/314311.html for additional tips on the format of a 510(k) 
submission. 
50  8   QUALITY SYSTEM  
 
INTRODUCTION ............................................................................................................... 51 
DESIGN CONTROLS ........................................................................................................ 52 
DEVICE MASTER RECORD ............................................................................................ 54 
DOCUMENT CONTROL ................................................................................................... 55 
INCOMING AND IN-PROCESS ACCEPTANCE ACTIVITIES ..................................... 56 
PROCESS VALIDATION .................................................................................................. 58 
PROCESS CONTROLS ...................................................................................................... 58 
FINISHED GLOVE ACCEPTANCE ACTIVITIES .......................................................... 63 
NONCONFORMING PRODUCT ...................................................................................... 64 
LABELING AND PACKAGING ....................................................................................... 64 
COMPLAINT HANDLING ................................................................................................ 65 
STERILIZATION ............................................................................................................... 67 
QUALITY SYSTEM AUDITS ........................................................................................... 69 
EMPLOYEE TRAINING .................................................................................................... 69 
EXHIBIT #1  SAMPLE GLOVE SPECIFICATION (DEVICE MASTER RECORD)..... 71 
EXHIBIT #2  SAMPLE COMPONENT RECORD (INCOMING CONTROLS) ............. 72 
EXHIBIT #3  SAMPLE IN-PROCESS RECORDS (IN-PROCESS CONTROL) ............. 73 
EXHIBIT #4  IMPACT OF MANUFACTURING PROCESSES (PROCESS CONTROL)
 ............................................................................................................................................. 74 
EXHIBIT #5  MONITORING AND PROCESS PARAMETER CONTROL RECORD .. 76 
 
 
INTRODUCTION  
 
Quality System Regulation 
 
Manufacturers of medical gloves must meet the requirements of the Quality System 
regulation for medical devices (21 CFR part 820).  The Quality System regulation at 21 CFR 
820.5 states that each manufacturer shall establish and maintain a quality system that is 
appropriate for the specific medical device...manufactured.  This system must meet the 
requirements of the Quality System regulation.   
 
Proper quality control procedures help to control or eliminate manufacturing defects, such as 
pinhole defects.  FDA also believes that compliance with the Quality System regulation and 
implementation of design controls will minimize water soluble proteins, chemical residues, 
and other problems common to the manufacture of medical gloves.   
 
This chapter provides guidance that is particularly relevant to the manufacture of medical 
gloves and other natural rubber latex medical devices.  This chapter does not cover all 
requirements of the Quality System regulation.   
 
51  DESIGN CONTROLS  
 
The design control requirements are basic controls needed to ensure that the device being 
designed will perform as intended when produced for commercial distribution.  Although 
surgeons gloves are subject to design control requirements (21 CFR 820.30(a)(2)(ii)),  
patient examination gloves are not.  
 
Design Input for Medical Gloves 
 
When developing design inputs for a new or modified glove design, you should answer 
questions pertaining to the intended use of the device as well as the needs of users and 
patients.  The questions and answers will vary for different types of gloves and accessories.  
Some typical design input questions include:  
 
  Where will the new glove be used? 
  Who will use the new glove? 
  How will the new glove be used? 
  With what devices will the new glove be used? 
  Does the glove need to be resistant to certain chemicals? 
  How long will the new glove be used?  
  What is the appropriate labeling and packaging?  
What are the regulatory requirements for the glove and any performance claims?  
  Are there any other questions that are specific to the glove you are developing? 
 
Design input requirements should identify all of the desired performance, physical, safety, 
and compatibility characteristics of the proposed glove design.  Design input also includes 
requirements for labeling, packaging, and manufacturing.  You should consider shelf life 
under design input as part of the activities to meet user and patient needs.  FDA considers 
shelf life to be a significant factor in meeting user needs.  The design input requirements are 
ultimately converted to the specifications for the finished glove. 
 
You must have a design input requirement procedure (21 CFR 820.30(c)) in order to develop 
the glove specifications.  The specifications, among other factors, should address: 
 
1.  Performance and efficacy; 
2.  Human factors, fatigue, donning, color, and odor; 
3.  Length, cuff, size, and thickness; 
4.  Chemical safety; 
5.  Allergenicity (protein levels); 
6.  Pinhole AQL; 
7.  Biocompatibility; 
8.  Glove compatibility with blood, saline and any intended chemical contact; 
9.  Environmental compatibility; 
10.  Packaging (in a separate specification document); 
11.  Labeling (which may provided in a separate document or in the glove primary 
specification, as appropriate);  
52  12.  Special labeling claims; 
13.  Any other regulatory requirements; and 
14.  Professional associations recommendations.  
 
The final glove specifications should cover all significant glove characteristics.  The glove 
specifications may refer to other specifications or standards.  Specifications should address 
characteristics or factors such as biocompatibility (chemicals and proteins), barrier integrity, 
packaging protection, shipping stability, and shelf life, if applicable.   
 
Design Verification  
 
You must establish and maintain procedures for verifying the device design (21 CFR 
820.30(f)).  Design verification confirms that the device design meets the design input 
requirements.  You should verify the design of gloves, packaging, and any subsequent 
changes by testing parameters such as tensile strength, elongation, barrier integrity 
(pinholes), protein residues, chemical residues, biocompatibility, correct labeling, and shelf 
life.  We recommend that you use test methods provided in recognized consensus standards 
for your verification testing whenever possible.  
 
Design Validation 
 
While design verification confirms that the device design (outputs) meets the design 
requirements (inputs), design validation is conducted to determine whether the device meets 
user needs.  The difference between design verification and design validation is illustrated in 
the following diagram: 
 
  
Validation for medical gloves may include use under real or simulated conditions.  
Validation assures that the donning ability, strength, thickness, feel, size, shape, texture, 
holding ability, tactile sensitivity, lack of fatigue, lack of irritation, color, and odor of the 
gloves are satisfactory to users. 
53   
Generally, clinical testing is not required for gloves that are substantially equivalent to gloves 
legally marketed in the U.S. However, if clinical testing is conducted, e.g., testing for skin 
sensitization to chemicals, you should perform appropriate laboratory and animal verification 
(e.g., performance, reliability, and biocompatibility) testing prior to human clinical or 
simulated use testing.  
 
DEVICE MASTER RECORD 
 
Title 21 CFR 820.3(j) states a Device master record means a compilation of records 
containing the procedures and specifications for a finished device.  A Device Master Record 
(DMR) is a comprehensive record of all of the procedures and instructions required to 
manufacture each type of glove.  A DMR contains or refers to the location of documents for 
manufacturing and processing activities, such as procurement, processing, labeling, test and 
inspection, and packaging.  The DMR also contains information on the design, formulation, 
specifications, complete manufacturing procedures, quality assurance requirements, 
acceptance criteria, packaging, and labeling of a finished glove.   
 
A DMR for medical gloves manufactured by complex processes, such as latex dipping, 
usually consists of many documents.  For convenience, many medical glove manufacturers 
generate an index or table of contents which lists all of the documents in a DMR.  The DMR 
should contain a glove (device) specification.  Generally, a medical glove specification will 
include the following: 
 
 product trade and common name(s) 
 intended use(s) 
 performance characteristics, such as tensile strength and elongation 
 regulatory classification 
 physical characteristics, such as cuffs, thickness, length, and size 
 environmental limitations and product shelf life or expiration date 
 user safety characteristics such as a pinhole and chemical residue limits 
 water-extractable protein limit 
 powder/particulate/debris limit 
 packaging and labeling specifications 
 
Exhibit #1 provides a sample specification for inclusion in the Device Master Record. 
 
A DMR should contain specifications for the content and design of labeling.  Labeling claims 
should match glove characteristics and contain required labeling.  Gloves that have false or 
misleading labeling are misbranded under section 502 of the Act.  (See chapter 4 on 
labeling.)   
 
Record Retention 
 
54  The Quality System regulation at 21 CFR 820.180(b) states All records required by this part 
shall be retained for a period of time equivalent to the design and expected life of the device, 
but in no case less than 2 years from the date of release for commercial distribution by the 
manufacturer.  You should retain records for most medical gloves for two years or for as 
long as the labeled expiration/shelf-life date, whichever is longer. 
 
DOCUMENT CONTROL 
Many written documents are needed to manufacture gloves.  Written procedures should 
cover the following areas:   
 
  glove design 
  processes  
  components, coagulants, dewebbers, donning lubricants  
  labeling and packaging 
  colorants, flavors, odorants, antimicrobials, anti-ozonants, anti-oxidants 
  environmental control, facilities, employee practices 
  production and measuring equipment  
  manufacturing materials 
 
Specifically, we recommend that written procedures  address the following: 
 
  cleaning tanks and equipment in accordance with a schedule 
  preventing or reducing of air bubbles during compounding 
  ball milling chemicals to yield proper size and prevent contamination 
  filtering compounded polymer solutions 
  inspecting formers on and off line for defects and debris 
  washing formers each (or as designated) line cycle 
  protecting wet formers from dust and other debris 
  controlling the environment by screening or closing doors and windows 
  protecting dipping tanks from dust and other debris 
  maintaining covers, shields, and ledges to reduce debris falling into processing tanks 
  controlling the use of grease and oil to eliminate drips into the processing tanks, 
  inspecting lines, tumblers, etc., to assure there are no protrusions, vibrations that 
could cause product defects 
  cleaning equipment  
  cleaning floors  
  maintaining floor or other waste material drains 
  controlling leach tanks function 
  controlling protein wash/rinse tanks function (i.e., manufacturing material is being 
removed) 
  controlling chlorination and neutralization 
  identifying and controlling finished gloves to prevent mix-ups 
55    analyzing defective gloves (when acceptance criteria are not met) to determine the 
cause of the problems,  
  personal hygiene, such as hand washing 
   
You should establish and maintain procedures to control all documents (21 CFR 820.40).  
Whenever there are changes to standard operating procedures, quality assurance procedures, 
data forms, and product specific documentation, the review and approval must come from 
individual(s) in the same function or organization that reviewed and approved the original  
(21 CFR 820.40(b)).  See the Quality System manual for additional information on change 
control. 
 
INCOMING AND IN-PROCESS ACCEPTANCE ACTIVITIES 
 
Components and Manufacturing Materials 
 
Components are materials used during manufacturing that are intended to be part of the 
finished gloves.  Examples of such products are latex concentrate, various chemicals that are 
mixed with the latex or polymer during compounding (such as antioxidants), and donning 
lubricant.   
 
Manufacturing materials are substances used to help in the manufacturing process but are not 
intended to become part of the finished gloves.  Examples include ingredients contained in 
the dipping compound (such as accelerators), former release chemicals, and any detergents 
that are used to clean the formers.  Corn starch (powder) is also a manufacturing material if it 
is added and then removed for powder-free gloves. 
 
Component Qualification 
 
Qualification is the determination of suitability of components and consists of verifying 
through documented testing, evaluation, and review that a manufacturing ingredient or 
component will reliably perform its function.  Well characterized manufacturing ingredients 
or components that are used in their normal application may need minor testing.  New 
products, such as donning lubricants, protein modified latex, or new accelerators, will require 
substantial testing.   
 
For surgical gloves, you should maintain a design history file of any qualification 
(verification) testing of components, raw materials, and manufacturing materials.  This 
record should include the product identity, testing methods that were used, who performed 
the testing, date, and the actual test data and results.   
 
Specifications for Incoming Components 
 
Specifications for components and manufacturing materials should state essential properties 
to assure the quality of the finished product.  The specifications should adequately describe 
the characteristics, dimensions, design, chemical purity, performance, and any other feature 
56  or parameter necessary to assure receipt of the product desired.  For some components, such 
as donning powder, the specifications should include a limit on microorganism 
contamination.  Component and material specifications should be part of the device master 
record.  
 
Natural rubber latex is a biologically produced substance that may vary considerably 
depending on climate, season, local environmental factors (including soil composition), and 
specific tree varieties.  Therefore, you should have as many applicable specifications for the 
incoming latex as feasible in order to reduce some of the inherent variability in this 
component.  You should be aware that various applicable standard tests and specifications 
are included in documents, such as ASTM D1076-02, Standard Specification for Rubber-
Concentrated, Ammonia Preserved, Creamed, and Centrifuged Natural Latex. 
 
Acceptance Criteria, Testing, and Documentation 
 
To the extent feasible, you should have specific acceptance criteria for components and 
manufacturing materials.  Acceptance criteria are the attributes of a product that determine its 
acceptability, such as appearance, color, dimensions, mechanical stability, percent solids, 
preservative levels, protein levels, viscosity, purity, pH, or performance characteristics.   
 
You should document the inspection, testing, and acceptance or rejection of raw materials, 
manufacturing ingredients, and components.  Exhibit #2 provides a sample record for 
receiving incoming latex.  
 
If you use a contract laboratory to test components, materials, and manufacturing materials, 
the laboratory becomes an extension of the glove manufacturers quality system.  The glove 
manufacturer is responsible for assuring that the contractors test and inspection procedures 
and quality system are acceptable.  Typically, you can obtain this assurance by documented 
audits. 
 
Component Storage 
 
You should store components so that they are protected from moisture, dirt, and insects.  You 
should store components or materials, such as latex and starch, in a manner that retards the 
growth of microorganisms.  FDA suggests that you store components and manufacturing 
materials under conditions that prevent their deterioration.  You may store ceramic formers 
and other items not affected by the environment in sheds or outside. 
 
In-Process Testing 
 
You should perform in-process testing on the dipping compound as well as the glove to 
determine if the manufacturing process is on target to meet your specifications.  In-process 
testing may include testing of the uncured compound, the cure status of the dipping 
compound (whether the compound is ready to dip), and thickness, tensile strength, length, 
and water leak testing of the glove.  Also, you should test for powder, if it is a powder-free 
57  glove.  You can find a sample of an in-process record, Analysis of Latex Compounding, in 
Exhibit #3. 
 
PROCESS VALIDATION 
 
Process validation is a means by which the manufacturer establishes that its manufacturing 
process is capable of consistently producing a product that conforms to the specifications as 
outlined in the device master record.  Process validation is a key element in developing 
process controls.  A properly validated and controlled process will reduce scrap and rework 
resulting in increased efficiency.  Examples of processes that should be validated include 
compounding, dipping, leaching, chlorination, sterile packaging, and sterilization.  
 
If there is an increase in nonconforming product or process deviations occur, you should 
review and evaluate the process, and you should perform revalidations where appropriate.  
Changes to the manufacturing process, such as new equipment or a new compound, may 
require revalidation prior to implementation of the change. 
 
 
PROCESS CONTROLS  
 
Each manufacturer must establish production and process controls, as appropriate, to ensure 
that a device conforms to its specifications (21 CFR 820.70(a)).  These controls should 
reflect the ranges of parameters established during the previously conducted process 
validation. 
 
You should consider process controls for the following processes: compounding, maturation, 
dipping, curing, bleaching, drying, powdering or removal of powder, and rinsing.  Also, you 
should control vibration which causes air bubbles in the dipping tanks.  Exhibit #4 shows a 
table providing the impact of processes that affect the finished glove characteristics.  The 
table provides examples of parameters for each process that you should consider for process 
controls.  Exhibit #5 provides a typical example of a monitoring and process parameter 
control record. 
 
 
Inadequate process control can lead to nonconforming product.  For example, patient exam 
gloves were insufficiently dried and subsequently packaged and distributed in a moist 
condition.  The lot was later tested and found to have Aspergillus and Fusarium molds and 
recalled from the market.  One way this situation may have been prevented is if the firm had 
monitored in-process controls during the manufacturing process.  Monitoring the humidity 
and/or moisture content during the drying cycle could have revealed the problem.  At this 
stage, the firm may have been able to rework (re-dry) the gloves which could have avoided 
the product recall.  
 
Manufacturing Materials 
 
58  Under the definition in 21 CFR 820.3(p) of the Quality System regulation, manufacturing 
materials include concomitant or by-product constituents.  Concomitant constituents are 
substances that are unavoidably present in the components and manufacturing materials but 
are not intended to be present in the finished device.  These include water-soluble natural 
rubber proteins present in the latex concentrate.  These proteins do not contribute to the glove 
barrier, because they are not bound into the latex film but readily leach out.  By-products are 
substances formed during mixing by reactions between various components and 
manufacturing materials.  These also include various calcium salts. 
 
Manufacturing materials such as mold release compounds, cleaning agents, lubricating oils, 
by-products, and other substances used to facilitate manufacturing are procured and received 
the same as components.  You should establish, maintain, and document procedures for the 
removal of manufacturing materials when they could reasonably be expected to have an 
adverse effect on product quality.  You should remove manufacturing materials or limit them 
to an amount that does not adversely affect the quality of the glove.  Because natural rubber 
latex proteins can adversely affect the safety of medical gloves, you should establish and 
validate procedures to reduce the water soluble proteins to ensure that it is removed or 
limited to an amount that does not adversely affect the gloves's safety. 
 
Control, Use, and Removal of Manufacturing Materials 
 
You should carefully consider manufacturing materials that may adversely affect the finished 
glove.  You should design each process to use a minimum amount of adverse chemicals to 
reduce costs and removal efforts and increase the safety of the glove. 
   
For medical gloves, processing of raw latex, and leaching and washing processes are 
commonly used to reduce or remove natural water-soluble proteins and remove adverse 
materials, such as processing chemical residues.  When residues from sterilization agents 
such as ethylene oxide need to be removed, instructions for aeration are necessary.   
 
When you add starch to medical gloves to expedite handling and then remove it during 
further processing (for example, during the production of some powder-free gloves), the 
starch becomes a manufacturing material.  You should use a written processing and 
test/inspection procedure to assure that powder residues on the finished gloves meet finished 
device specifications. 
 
Water-Soluble Proteins.  Water-soluble proteins on latex gloves may be a potential cause of 
allergic reactions.  Processing controls should include the reduction of water-soluble 
proteins.  You should remove them by:  
 
  reducing or removing the proteins in the raw latex, 
  using and controlling pre-cure leaching and post-cure washing processes, 
  assuring that the leaching tanks and spray or washing tanks use water that is flow-
controlled and continually refreshed to avoid protein saturation, and  
  leaching and washing for an appropriate time. 
 
59  You should perform washing before and after curing, because proteins become more water-
soluble and/or move to the surface of latex gloves during heat curing.  This allows you to 
remove the protein more efficiently.  You should complete the washing before you apply the 
final donning powder or lubricant, if applied.  
 
Each manufacturer should establish the temperature of the leaching and washing water 
because the temperature needed varies based on the parameters of the overall compounding, 
dipping, and curing methods.  Studies indicate that the purity (flow rate) and agitation of the 
leach water and total leaching time are more important than water temperature. 
 
Surface treatment of the cured latex glove with chlorine or similar agents denatures surface 
constituents such as water-soluble proteins.  These treatment processes also wash and rinse 
away proteins and manufacturing residues.  Chlorine is an adverse manufacturing material 
which can cause deterioration of the gloves.  You should remove it from the gloves after 
chlorination by washing, neutralization, or other appropriate methods.  The chlorination 
process includes process control and validation. 
 
You should test water-soluble proteins during routine production.  You may test protein 
levels using the FDA-recognized standard, ASTM D5712, Standard Test Method for the 
Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the 
Modified Lowry Method, or an equivalent consensus standard. 
 
Trained personnel should develop, validate, document, implement, and control the processes 
used to control water-soluble proteins and manufacturing materials (see 21 CFR 820.25). 
 
Manufacturing Chemicals.  You should remove manufacturing chemicals, such as 
vulcanization accelerators and detergents, to the extent that they do not adversely affect the 
finished glove.  Reports of type IV sensitivity reactions have been associated with gloves that 
contain residual amounts of these manufacturing chemicals.  
 
You can remove manufacturing chemicals by some of the same methods used to remove 
protein.  You should develop leaching, washing, surface treatment, or other processes for 
removing adverse manufacturing materials.  You should also validate, document, and 
continuously control the processes in order to meet the established specifications.   
 
Maintenance and Inspection of Equipment 
 
According to 21 CFR 820.70(g)(1), you must establish and maintain a schedule for the 
adjustment and cleaning of equipment.  For example, you should periodically strip and clean 
the maturation tank of any residue to avoid contamination.  The formers should have a 
routine cleaning schedule because build up of residues can cause thin spots and holes in the 
gloves.  In addition to the in-line cleaning, you may need periodic maintenance of formers to 
remove the build up of residues.  You should lift, or remove and repair, or replace defective 
formers.  Because lubricant for production equipment can fall into dipping tanks, you should 
inspect the equipment for excess lubricant and periodically clean the equipment. 
  
60  To properly maintain equipment, manufacturers should: 
  establish a written schedule for performing these activities, 
  post the schedule or make it readily available to employees,  
  document the activities, the individuals conducting the activities, and the date, 
  audit the activities and document the audit, and 
  keep maintenance records for each piece of equipment. 
 
When adjustment is necessary to maintain proper operation due to deterioration of parts 
or other reasons, post the inherent limitations and allowable tolerances of the equipment 
or make these readily available to personnel responsible for making adjustments.  
 
Contamination Control 
 
For each area in the building where you process components and gloves, you should control 
any element that you determined might cause contamination.  The contaminants include dust, 
paint chips, rust, starch residues, protein residues, microorganisms, humidity, temperature, 
and static electricity.  If sources of contaminants are located above the manufacturing 
equipment, you should consider covering or enclosing portions of the dip line or any other 
area that could be affected by debris.  You should clean equipment as needed by methods 
that will reduce or prevent contamination of tanks, formers, and gloves with dust and other 
debris. 
 
Buildings should be appropriately constructed to prevent, reduce, and control contamination, 
and support the manufacturers environmental control program.  For example, controlling 
dust may require that you pave driveways and parking lots.  Floor sweeping and floor 
polishing scatter dust can contaminate wet formers, coagulant dipping tanks, latex/polymer 
dipping tanks, and finished gloves.  You should clean floors and equipment by methods that 
minimize the amount of debris released into the environment.   
 
You should perform all manufacturing and labeling operations for low protein or synthetic 
gloves in a separate area to avoid protein contamination by latex gloves.  Synthetic polymer 
gloves, polymer-coated latex gloves, or any gloves with a labeled or controlled protein level 
should not be dipped in any tank (particularly starch slurry tanks) or tumbled in dryers where 
regular protein coated latex gloves have been produced, unless you clean the tanks 
thoroughly before the production of the low- or protein-free gloves.  FDA recommends that 
manufacturers dedicate lines specific to the manufacture of synthetic gloves to avoid protein 
contamination.   
 
61  Environmental Control 
 
Where environmental conditions could reasonably be expected to have an adverse effect on 
product quality, you must establish procedures to control the environmental conditions (21 
CFR 820.70(c)).  You should establish and maintain an appropriate system for regular 
monitoring and documenting the control of environmental factors that apply to your specific 
situation. 
 
You should consider environmental factors, such as lighting, ventilation, temperature, 
humidity, static electricity, insect and pest control, and particulates.  If you use rodenticides, 
insecticides, or similar agents, you should establish written procedures for limiting their use 
and removing them from work surfaces.  These procedures are to prevent any adverse effect 
on the manufacturing process or the device.  You should cover finished gloves, solution 
tanks, and other appropriate items during the application of pesticides to the room.   
 
You should store packaging and starch in a clean, dry, insect-free area.  You should preserve 
latex to prevent bacterial growth.  You should store components such as starch that support 
bacterial growth in a controlled environment such as sealed containers or bags.  You should 
not use unfiltered air to dry washed formers or coagulant-coated formers, because the 
resulting contamination may cause pinholes.  You should not use unfiltered factory air to 
cool or dry finished surgeons gloves.  You should have screens in open windows, and doors 
should be screened to control insects. 
 
Bioburden Control 
 
Bioburden is an environmental factor that needs to be controlled for sterile surgeons gloves, 
but it is also important in the manufacture of nonsterile gloves.  The failure to control 
bioburden may result in mold on the finished product.  
 
Medical gloves, particularly those powdered with starch, can support the growth of micro-
organisms.  Appropriate processing controls should include: 
 
  purchasing starch with a low bioburden, 
  properly storing the starch until it is used, 
  applying starch per established procedures, 
  cooling the starch slurry and/or using an antimicrobial in the starch slurry tanks, 
  sampling finished gloves to assure that excessive starch is not applied, 
  keeping the finished gloves clean, 
  establishing and meeting a dryness specification for finished gloves, and 
  protecting finished gloves from the environment. 
 
Filthy or contaminated water may also be a major source of microbes on finished gloves.  
You should monitor and appropriately treat water used in processing the glove, especially 
near the end of the manufacturing process, such as post-cure washing, to control the 
bioburden on the glove.  
 
You should refer to ANSI/AMMI/ISO 11737-1:1995, Sterilization of Medical Devices
62  Microbiological methodsPart 1: Estimation of Population of Microorganisms on Product 
for guidance on bioburden testing. 
   
Personnel Practices 
 
You should establish and maintain procedures for personnel to follow to reduce 
contamination and any other adverse effects on the gloves.  Procedures should include hand 
washing requirements.  Personnel should not wear jewelry or have sharp fingernails.  
Additionally, eating and smoking may adversely affect the finished glove.  You should 
confine these activities to designated areas.   
 
FINISHED GLOVE ACCEPTANCE ACTIVITIES 
 
Finished glove acceptance procedures should demonstrate that the gloves meet the 
manufacturers acceptance criteria.  The finished device evaluation should include inspection 
and testing of samples of packaged gloves.  A manufacturers evaluation of finished glove 
lots usually includes appropriate in-process inspection and testing performed on 
representative samples.  You should record the evaluation data for finished glove lots in the 
device history record (DHR).  You should review and accept the DHR before releasing the 
lot for distribution.   
 
Glove evaluation may include the following parameters: 
 
  barrier integrity, including pinholes and embedded debris, 
  length, width, thickness, 
  weight, 
  elongation and tensile strength, 
  cuffs/beads, 
  powder and/or lubricant level, 
  measurement or indication of manufacturing material residues, 
  measurement or indication of proteins or allergens, 
  moisture content or dryness level, 
  fisheyes, webbing, or folds, 
  package integrity, 
  bioburden count,  
  labeling, 
  visual tests, such as color and material uniformity. 
 
Your quality system procedures should describe the finished device test methods and 
acceptance criteria, including sampling procedures and AQL.  You should reference any 
standard test methods that are used.  Information on test methods for water leak testing, 
protein, tensile strength, and powder residue is available in consensus standards.  See Chapter 
10, Voluntary Standards, for more information on consensus standards.  For water leak 
testing, FDA uses the methodology in 21 CFR 800.20 for its regulatory testing of all medical 
gloves (of all materials).  
 
63  NONCONFORMING PRODUCT 
 
If a lot of gloves or product does not meet specifications, you should properly identify the 
containers of rejected gloves and place them in a separate quarantine area or in a specially 
identified area to prevent mix-ups.  If nonconforming product is investigated, you should add 
the results to the corrective and preventive actions (CAPA) system.  According to 21 CFR 
820.90(b)(1), you must document the disposition of nonconforming product.  The records 
should state whether you returned or scrapped the gloves, components, materials, or other 
products.   
 
Reworked Gloves  
 
You must establish and maintain procedures for rework to include retesting and reevaluation 
of reworked nonconforming product (21 CFR 820.90(b)(2)).  Reworked product should meet 
the original specifications.  You should evaluate reprocessing to assure that gloves will not 
be adversely affected and you should document the results of the evaluation.   
 
Procedures for reworking should specify the types of nonconformances that may be 
reworked.  These procedures should document the specific tests and processes to be 
performed.  You should base these procedures on studies that measure the effects of 
reprocessing operations.   
 
Reworked product is nonconforming product until it meets all finished device acceptance 
criteria.  You should identify reworked product to distinguish it from acceptable product and 
components. 
 
LABELING AND PACKAGING 
 
The Quality System regulation has specific requirements for labeling and packaging design, 
as well as for labeling and packaging operations (21 CFR 820.120, 820.130)).  Labeling 
includes dispenser box labels, case labels, package labels, and directions for use, such as 
caution statements. 
 
Area Separation and Inspection 
 
You should separate all labeling and packaging operations performed at the same time, as 
necessary, to assure there are no mix-ups between similar labels or various sizes or types of 
gloves.  Before beginning any packaging and labeling operation where a mix-up could occur, 
you should examine the production area and equipment to make certain that you have 
removed any glove and labeling materials from previous operations.  You should destroy 
unused labeling that contains a pre-coded manufacturing date, expiration date, or lot number; 
you should not return it to the label storage area.   
 
64  A designated individual should examine the labeling for accuracy, in accordance with the 
device master record, prior to initiating the labeling operation.  The examination should 
include the expiration date. 
 
Packaging 
 
An effective primary package for a medical glove should be designed and developed along 
with the product by considering glove characteristics, contamination control, sterilization 
process, sealing, labeling, secondary packaging, shipping, environment, shelf life (expiration 
date), end use, and FDA regulations.  The primary package and the shipping container should 
protect gloves adequately under all reasonable conditions from original packaging to final 
use.  For sterile gloves, you should validate the packaging operation.  You should either 
compile complete storage and stability data for packaging for sterile gloves or obtain the data 
from the packaging supplier. 
 
Shipping for Further Processing 
 
It is common industry practice for non-sterile gloves labeled as sterile to be shipped to a 
contract sterilizer.  You should conspicuously mark each pallet, carton, or other designated 
unit to show its non-sterile nature when it is introduced into and is moving in interstate 
commerce.  See Sterilization for additional information. 
 
COMPLAINT HANDLING 
 
Each manufacturer must process complaints from all sources according to its complaint 
handling procedure (21 CFR 820.198(a)).  You should assure that personnel in marketing, 
sales, engineering, and manufacturing report complaints.  You should make these employees 
aware of this Quality System requirement through formal training and note the training in 
their training records.   
 
Because FDA believes that customer complaints are underreported, user reporting for tears 
and leaks are considered low.  Therefore, even small increases in the rate of complaints may 
be significant. 
 
Customer complaints may include the following issues: 
  
[ ]  Pinholes, Tears, Thin Spots, Degradation    
[ ]  Expiration Date / Shelf Life    
[ ]  Powder, Lubricant, Tacky    
[ ]  Particulates:  Type _________________ Location    
[ ]  Packaging    
[ ]  Sterility    
[ ]  Labeling    
65  [ ]  Thickness, Mold, Appearance, Attributes    
[ ]  Dermatitis    
[ ]  Allergic Reaction    
[ ]  Describe Other Defects    
 
Complaint Analysis    
Each complaint needs to be reviewed by a designated unit and a decision made as to whether 
an investigation is needed.  The analysis of the complaint typically includes the following 
information: 
 
Sequential Complaint Number    
Glove Type    Cat.  Number    
Date of Complaint Report    Lot Number    
Name of Complainant    
Nature of Complaint    
ASSIGNEE EVALUATION & CONCLUSIONS:    
   
   
   
   
   
[ ] Pinholes, Tears, Thin Spots, Degradation    
[ ] Powder, Lubricant, Tacky    
[ ] Particulates    
[ ] Labeling/Packaging    
[ ] Non-Sterile    
Thickness, Appearance, Color Attributes of:  
[ ] Fingers  [ ] Palm    
[ ] Crotch   [ ] Cuff/bead    
[ ] Elongation   [ ] Tensile    
[ ] Chemical Residues Above Spec.     
[ ] Protein Level Above Spec.     
[ ] Improper Use    
[ ] Shipping Damage    
[ ] Describe Other Defects/Problems    
   
   
   
ACTION:    [  ] Recalled         [  ] Replaced         [  ] Credited         [  ] Sales Follow-Up 
[ ] Letter    
Investigation needed  []Yes       []No 
[ ] Referred To    for Further Investigation or Correction 
[ ] NONE.  Reason for no action    
66     
   
NOTES:    
   
FINAL DISPOSITION    
   
   
Reviewed by:  Quality Assurance    Date    
If requested:  Engineering    Date    
Production    Date    
 
Complaint Investigation  
 
Each manufacturer must evaluate complaints to determine whether an investigation is 
necessary (21 CFR 820.198(b)).  After an analysis of the complaint, if an investigation is 
needed, the failure investigation and analysis should determine the actual problem or actual 
failure mechanism to the level necessary to correct the problem.  A failure investigation may 
include  a review of the device history records and analysis of returned product.  When you 
diagnose the same failure, contaminant, or other problem several times, you do not need to 
analyze all additional gloves that are returned with the same complaint. 
 
Complaints Received by Distributors 
 
When the manufacturer is located outside the U.S., the foreign manufacturer should provide 
the U.S. distributor with instructions to forward any complaints to the foreign manufacturer 
for review and analysis.  You should consider the forwarding of complaints when developing 
contracts or other business arrangements with importers. 
 
Medical Device Reporting 
 
According to 21 CFR 820.198(a)(3), you must evaluate complaints to determine whether the 
complaint represents an event which must be reported to FDA under 21 CFR 803, Medical 
Device Reporting.  Incidents in which a device may have caused or contributed to a death or 
serious injury must be reported to FDA under the Medical Device Reporting program.  In 
addition, you must report certain malfunctions. (21 CFR 803.1.) An allergic reaction may be 
considered a reportable event. 
 
The MDR regulation is a mechanism for FDA and manufacturers to identify and monitor 
significant adverse events involving medical devices.  The goal of the regulation is to detect 
and correct problems in a timely manner.  You can find additional information on the 
Medical Device Reporting process at: http://www.fda.gov/cdrh/devadvice/351.html  
 
STERILIZATION 
 
67  Sterilization of medical gloves should meet a sterility assurance level (SAL) of 10-6.  This 
means that you should design the sterilization process so that the probability of a glove being 
non-sterile is 1 in 1,000,000, even if the gloves originally contained highly resistant 
microorganisms. 
 
You should sterilize medical gloves with a validated sterilization process.  Note that some 
glove materials are adversely affected by certain sterilization methods.  Validation of the 
sterilization method should demonstrate that the sterilization process does not adversely 
affect glove safety and effectiveness. 
 
Refer to  the Quality System manual and applicable standards, such as AAMI or ISO, for 
validation of sterilization processes. AAMI and ISO standards for sterilization include the 
following: 
 
  ANSI/AAMI/ISO 11135- Medical devices - Validation and routine control of ethylene 
oxide sterilization 
 
  AAMI/CDV 11137 Sterilization of health care products  Radiation 
 
  AAMI/ISO Technical Information Report (TIR) 13409 Sterilization of health care 
products - Radiation sterilization 
 
Additional AAMI standards are available at 
http://www.aami.org/applications/search/index.cfm?currentcategory=Sterilization  
 
Contract Sterilization 
 
It is common industry practice to ship non-sterile gloves labeled as sterile to a contract 
sterilizer.  This practice is recognized in 21 CFR 801.150(e) which states, in part, the Food 
and Drug Administration will initiate no regulatory action against the device as misbranded 
or adulterated when the non-sterile device is labeled sterile, provided all the following 
conditions are met: 
 
(1) There is in effect a written agreement which: 
 
(i)  contains the names and post office addresses of the firms involved and is signed by 
the person authorizing such shipment and the operator or person in charge of the 
establishment receiving the devices for sterilization, 
(ii)  provides instructions for maintaining proper records or otherwise accounting for the 
number of units in each shipment to insure that the number of units shipped is the 
same as the number received and sterilized, 
(iii)  acknowledges that the device is non-sterile and is being shipped for further 
processing, and 
(iv)  states in detail the sterilization process, the gaseous mixture or other media, the 
equipment, and the testing method or quality controls to be used by the contract 
sterilizer to assure that the device will be brought into full compliance with the Act.   
68   
(2) Each pallet, carton, or other designated unit is conspicuously marked to show its non-
sterile nature when it is introduced into and is moving in interstate commerce, and while 
it is being held prior to sterilization.  Following sterilization, and until such time as it is 
established that the device is sterile and can be released from quarantine, each pallet, 
carton, or other designated unit is conspicuously marked to show that it has not been 
released from quarantine, e.g., sterilizedawaiting test results or an equivalent 
designation.  
 
Compliance with 21 CFR 801.150(e) may require two written agreements when importing 
pre-labeled sterile but not-yet-sterilized surgeons gloves.  The two agreements are: 
 
  one between the importer and the glove manufacturer, and 
  one between the importer and the contract sterilizer. 
 
Gloves that have been sterilized and shipped to the importers warehouse prior to final 
release of the product should be properly marked as not yet released.  For example, pallets or 
other designated units may be marked sterilized, awaiting test results, or similar wording.  
The importer should have control of the gloves until final release.  Prior to shipping, you 
should use either a highly controlled quarantine area or a label control system to prevent 
distribution of gloves marked sterile, but not yet released for distribution. 
   
QUALITY SYSTEM AUDITS 
 
Under 21 CFR 820.22, you must conduct quality audits to assure that the quality system is in 
compliance with the established quality system requirements and to determine the 
effectiveness of the quality system.  Individuals who do not have direct responsibility for the 
area being audited must conduct the quality audits.  You must take corrective action(s), 
including a reaudit of deficient matters, when necessary.  You must document the results of 
each quality audit, (and reaudit(s), if necessary) in a report, and management responsible for 
the area audited must review the report (21 CFR 820.22). 
 
You should establish written procedures for quality audits.  You should document the dates 
and results of quality audits and reaudits.  
 
EMPLOYEE TRAINING 
 
Under 21 CFR 820.25, you must have sufficient personnel with the necessary education, 
background, training, and experience to assure that all activities required by the Quality 
System regulation are correctly performed.  As part of their training, personnel must be made 
aware of device defects that may occur from the improper performance of their specific jobs.  
Personnel who perform verification and validation activities must be made aware of defects 
and errors that may be encountered as part of their job functions.  
 
69  You must establish procedures for identifying training needs and ensure that all personnel are 
trained to adequately perform their assigned responsibilities.  You must document employee 
training (21 CFR 820.25). 
 
 
70  EXHIBIT #1  SAMPLE GLOVE SPECIFICATION (DEVICE MASTER RECORD) 
 
*** SAMPLE DEVICE MASTER RECORD EXAMINATION GLOVE 
SPECIFICATION *** including some typical parameters.   
You may modify this form and use it to meet your needs.  Do not use this example as is. 
 
C O M P A N Y  L O G O  Page 1 of  1 
Title: Glove Specification  SOP Number 
Prepared by:   Date Prepared    
Approved by:    Date    Rev C 
ECN notes:  ECN 429 Protein limit added 8-1-96; no label claim -- no new 510k required; ECN 436  Rev B  
powder level changed to 10mg/decimeter 2  
ECN 438 Rev C protein reduced to 200 g/decimeter 2 by process improvement 
 
COMPANY PRODUCT NAME:  _________________ 
Trade Name:  Patient examination gloves, non-sterile 
Intended Use:  Medical activities except surgery 
U.S. FDA Status:  Class I, Classification Number 80LYY; 510(k) marketing clearance required. 
 Should be manufactured under quality system program. 
 
Material:  Natural rubber latex   
Donning Lubricant:  U.S.P.  Absorbable corn starch 
Catalog Numbers:  Crystal Touch 100S  | Crystal Touch 100M  | Crystal Touch 100L   
Sizes:   Small  | Medium  | Large 
Conforms to following 
Standards:  ASTM D3578, ISO 11193     
Overall Length:   240 mm minimum  |  240 mm minimum  | 240 mm minimum   
Width:   80 +/- 10 mm  |  95 +/- 10 mm  | 111 +/- 10 mm   
Palm Thickness:   0.10 mm minimum   
Finger Thickness:   0.10 mm minimum   
 
 BEFORE AGING at 70C  |  AFTER AGING at 70C 
Tensile Strength:   18 Mpa minimum  |  14 Mpa minimum   
Ultimate Elongation:   650% minimum  |  500% minimum   
 
Orientation:   Ambidextrous   
Cuffs:    Yes   
Color:    Natural   
Residual Powders   10mg/decimeter 2 max.   
Protein Max.   200 g/decimeter 2  max. 
 
Packaging:   100 units in dispenser box by weight 
Disp.  Carton Labeling:   Per Packaging specification P-192 Rev.  C 
Ship.  Case Labeling:   Per Packaging specification P-193 Rev.  B 
Product Coding:   
 
******************************* End ********************************** 
71  EXHIBIT #2  SAMPLE COMPONENT RECORD (INCOMING CONTROLS) 
 
*** SAMPLE RECORD ***  Page ___ of___       
Do not use without modifying to meet your specific glove and operations. 
 
RECEIVING LATEX TEST DATA                                                                        PROCEDURE NO.* 
SUPPLIER:  Date Received 
SOURCE:  Date Sampled 
LATEX GRADE:  Lot 
PARAMETER  ACCEPTANCE  RESULTS  Tested by and date  PASS/FA
CRITERIA   IL 
% TOTAL SOLID CONTENT         
MST (sec)         
% DRY RUBBER CONTENT         
% NON-RUBBER CONTENT         
% ALKALINITY ( NH % )         
3
VFA NUMBER         
KOH NUMBER         
VISCOSITY         
pH VALUE         
OTHER:         
Remarks:  
 
 
 
Reviewed by (signature):  Date 
 
 
72  EXHIBIT #3  SAMPLE IN-PROCESS RECORDS (IN-PROCESS CONTROL) 
 *** SAMPLE RECORD *** 
Do not use without modifying to meet your specific glove and operations. 
 
ANALYSIS OF LATEX COMPOUNDING 
 DATE   SHIFT 
Batch Number                 
Compounding Tank No.   
Date & Time Compounded   
Date and Time of Test   
  PROCEDURE*  RESULTS BEFORE   
NUMBER (Spec)  MATURATION  PASS/FAIL 
1.  pH        
2.  TSC       
3.  Precure test        
4.  NH         
3
5.  VISCOSITY        
6.  OTHER        
  PROCEDURE*  RESULTS  AFTER   
NUMBER (Spec)  MATURATION  PASS/FAIL 
1.  pH        
2.  TSC        
3.  Precure test       
4.  NH         
3
5.  VISCOSITY        
6.  OTHER       
Remarks: 
 
*The test & acceptance activities performed & equipment used are described in the procedures 
Tested by: 
Signature: 
 
73  EXHIBIT #4  IMPACT OF MANUFACTURING PROCESSES (PROCESS CONTROL) 
This chart indicates the possible effects of various process parameters on the performance characteristics of gloves.  It can be used as a checklist 
for the design of gloves and associated processes.  It does not cover all possible parameters.  It is in keyword form; therefore, it should be used by 
appropriately trained persons.  Do not use this checklist without modifying it to meet your specific approach to glove and process design.   
 
        REACTIONS PHYSICAL PROPERTIES AND SURFACE CHARACTERISTICS 
  a  b  c  d  e  f  g  h  i  J  k  l  m  n  o  p  q  r  s  t  u  v  w  x 
 
  y  5) 
   CP1.RO  OMRCPAEOWSNS LEEANS TTES,X  P - ANRoAn MRuEbTbeErR SSo,l iAdsN; DA mmonia;  Irritation   Type IV Allerg Type I Allergy   Barrier   Shelf Life       Tack / Grip   Bricking   Blocking   Particles   Discoloration ( Extractables    Donning Ease   Comfort   Roll Down   Hand Fatigue  Thickness   Uniformity    Bioburden   Endotoxins   Spoilage   Modulus       
Copper & other metals; Centrifugation; Maturation 
2.  FORMULATION - Selection; Amount Added;                                                
Amount processed out (removed) 
3.  CHEMICALS - Chemical purity; Microbial                                                 
purity; Particle size; Supplier Change control  
4.  PRE-PROCESSING - Ball milling or grinding                                                 
efficiency; Premixing 
5.  COMPOUNDING - Correct ingredients;                                                 
Correct order; Cleanliness; Homogeneity; 
Maturation; Stir / Fill bubbles 
6.   FORMERS - Dimensions; Orientation; Length;                                                
Composition; Surface texture; Embossing; Cuff 
Width; Rotation; Dynamics; Age/wear 
7.   COAGULANT - Composition; Agitation;                                                 
Former temperature / dry; Agitation 
8.  LATEX DIP - Temperature; Agitation; Level;                                                 
Dwell; Foam; Drip; Fallout 
9.  SET - BEAD  (1)                                                 
10.  LEACH - Temperature; Water direction; Water                              (6)                   
speed; Dwell time; Depth; Fresh Water ratio; Water 
purity 
74    a  b  c  d  e  f  g  h  i  J  k  l  m  n  o  p  q  r  s  t  u  v  w  x 
 
  y  5) 
   CP11RO. OMOCPVEOESNNSEESN S-  TTSem,  pPeAraRtuArMe PErTofEilRe;S D, wAeNllD;  Air  Irritation   Type IV Allerg  Type I Allergy   Barrier   Shelf Life       Tack / Grip  Bricking   Blocking   Particles   Discoloration (  Extractables   Donning Ease    Comfort   Roll Down   Hand Fatigue   Thickness   Uniformity  Bioburden   Endotoxins    Spoilage   Modulus       
circulation; Humidity    (2) 
12.  POST-CURE RINSE POWDERED GLOVES                                                
Purity; Volume; Duration; Exposure   
13.  POWDERED GLOVE SLURRY -                                                 
antimicrobial; Surfactants; Ingredients; Temperature; 
Amount used; Agitation; Microbial growth; Clean 
out frequency   (3) 
14.  CHLORINATION POWDER FREE                                                 
GLOVES - Concentration; Filtration; Duration; 
Load; Reversals; pH; Agitation; Drain efficacy and 
speed;  Neutralization; Rinse Quality 
15.  LUBRICANT  - Type; Concentration;                                                 
Distribution; Microbial Growth 
16.  DRYERS - Delay; Temperature; Duration;                                                 
Cross Contamination; Humidity; Filtration; Load / 
Space; Airflow 
17.  PACKAGING - Line Clear; Clean up; Label                                                 
control; Packaging material; Stack method; Sun / 
light exposure   
18.  TRANSPORT / STORAGE - Temperature;                                                 
Moisture; Protection; Insulation 
19.  CLEANING - HOW?  WHEN? - Formers;                                                 
Filters / Screens; Tanks; Mop (no sweeping); Air / 
Surface; Line Change; Personnel; Chain guards 
20.  COATINGS - Laminates, Bound polymers (4)                                                 
21.  EXTRACT TREATMENTS - Enzymes,                                                 
Protein binders 
22.  Other                                                  
(Add for your glove and processes) 
75  EXHIBIT #5  MONITORING AND PROCESS PARAMETER CONTROL RECORD  
SAMPLE  *** Do not use without modifying to meet your specific needs. ***   
 
MACHINE DIP LINE PARAMETERS PER DAY 
LINE:    SHIFT:    DATE:    
OPERATOR:    SUPERVISOR:      
ITEM OR PROCESS        TIME  &  PARAMETER   ACTION 
TAKEN 
1.  Acid tank 55-600 C.         
Level         
2.  Rinse 45-500 C.         
Level         
3.  Water 55-600 C.         
Level         
4.  Wash oven 80-850 C.         
5.  Coagulant 50-550 C.         
Level         
6 Coagulant oven 80-850 C         
7.  Latex dip 27-290 C.         
Level         
8.  Tack oven 85-900 C.         
9.  Beading         
10.  Leaching 55-650 C.         
(1)  Level in tank         
11.  Leaching 55-650 C.         
(2)  Level in tank         
12.  Cure oven #1 temp.         
13.  Cure oven #2 temp.         
14.  Cure oven #3 temp.         
15.  Protein Rinse operating         
Chain speed          
Line start time         
Line stop time         
~ items produced / hour          
Length of glove (23-24 cm)         
Weight of glove (gm)         
Reject weight (kg)         
Remarks 
76  9  COMPLIANCE ACTIVITIES 
 
FACTORY INSPECTIONS  77 
IMPORTING GLOVES  AND FDA SAMPLING  77 
COMPLIANCE ACTIVITIES  78 
DETENTION  80 
IMPORT ALERTS FOR MEDICAL GLOVES  81 
APPENDIX A - SUGGESTED GLOVE TESTING APPARATUS  83 
 
FACTORY INSPECTIONS 
 
FDA evaluates manufacturer compliance with the medical device regulations primarily by 
factory inspections.  During the inspection, the FDA investigator will review your facilities, 
design controls (for surgeons gloves), manufacturing operations, environment, and records 
to determine your level of compliance.  The emphasis will be on compliance with the Quality 
System regulation (21 CFR part 820).  The FDA inspection program includes foreign 
manufacturing sites.  FDA will contact foreign firms to schedule an inspection.   
You will find guidance on how FDA conducts factory inspections, including regulatory 
sanctions FDA can take against noncompliant firms, in the following guidance documents.  
 
Factory Inspections (Medical Device Quality Systems Manual: A Small Entity 
Compliance Guide) 
http://www.fda.gov/cdrh/qsr/18inspn.html  
 
Quality System Inspection Technique (QSIT) 
  http://www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm 
 
IMPORTING GLOVES  AND FDA SAMPLING 
 
You will find information on the FDA import process at 
http://www.fda.gov/cdrh/devadvice/39i.html.  FDA may collect a sample of your gloves and 
test the gloves in accordance with 21 CFR 800.20, Patient examination gloves and 
surgeons gloves; sample plans and test method for leakage defects; adulteration.  Sketches 
of the test apparatus described in 21 CFR 800.20 are provided in Appendix A. 
 
When a glove shipment includes multiple lots or sizes, it is considered a commingled 
shipment.  FDA usually will not sample each individual lot within a commingled shipment.  
In the sample, FDA will include only one type of glove (surgeons gloves or examination 
gloves) and will attempt to represent glove sizes in the sample as they occur in the overall 
shipment.  Also, FDA will attempt to include several lot numbers, if present.  However, exact 
proportional representation of all lots or sizes is not necessary to obtain a representative 
sample for testing.  A shipment of gloves may be refused entry based on the appearance of 
adulteration (Section 801 of the Act; 21 U.S.C. 381), and such an appearance can be obtained 
even if the sample includes only one lot number or one size.  If the sample fails, FDA will 
77  detain all lots of the same glove type (surgeons gloves or examination gloves) in the 
shipment.   
 
FDA provides its sampling methodology and defect action levels in the FDA Compliance 
Policy Guide, Chapter 3, Section 335.700, Surgeons Gloves and Patient Examination 
Gloves; Defects - Criteria for Direct Reference Seizure.   
 
CPG 335.700 Surgeons Gloves and Patient Examination Gloves; Defects - Criteria for 
Direct Reference Seizure (CPG 7124.31) 
  http://www.fda.gov/ora/compliance_ref/cpg/cpgdev/cpg335-700.html 
 
COMPLIANCE ACTIVITIES 
 
FDA may pursue regulatory sanctions when medical devices are determined to be 
"adulterated" or "misbranded," or when individuals or firms commit certain "prohibited acts."  
(Sections 301, 501, and 502 of the Act; 21 U.S.C. 331, 351, and 352.) These generic terms 
also apply to other products that FDA regulates, such as foods, drugs, and cosmetics; 
however, the causes of adulteration and misbranding are not identical for all products.  The 
following summarizes some common reasons why FDA may consider medical gloves to be 
adulterated or misbranded.   
 
Adulteration  
 
Generally, a charge of adulteration indicates a potentially serious problem with the medical 
device itself.  Section 501 of the Act describes possible reasons for adulteration.  Several 
common examples of adulterated medical gloves are: 
 
  Gloves that do not provide an intact barrier as evidenced by failure of a water leak test 
(21 CFR 800.20). The gloves are adulterated according to section 501(c) - failure of the 
gloves to have the quality that they are represented to have. 
 
  Gloves that have never been cleared to market are automatically classified in Class III 
(section 513(f)(1) of the Act).  Without clearance or approval, the gloves are adulterated 
according to section 501(f)(1)(B)(i). 
 
  Gloves that have been manufactured, packaged, or stored in a facility that was inspected 
by FDA and that was found not in conformity with the Quality System regulation (21 
CFR part 820).  The gloves are adulterated according to section 501(h) because the 
facilities and controls used for manufacturing, packing, and storage do not meet GMPs as 
described in the Quality System regulation (21 CFR 820). 
 
78  Misbranding 
 
Usually, a charge of misbranding indicates a problem with the labeling or documentation of 
the device or device manufacturer. Section 502 of the Act describes possible reasons for 
misbranding.  Several common examples of misbranded medical gloves are: 
 
  Gloves that have exaggerated, untrue, or unsubstantiated claims are misbranded under 
section 502(a) of the Act, because the labeling is false or misleading in some manner.  
Examples of claims that may  misbrand a medical glove include: 
 
  Leak Proof or similar unsupportable claims of performance 
  Hypoallergenic claims for latex gloves (prohibited by 21 CFR               
801.437(h))  
  Antimicrobial claims without supporting data 
  Accelerator Free  
  Skin Care claims without supporting data 
  Synthetic Gloves that do not identify the material 
  Low Protein claims that do not quantify the amount of protein 
  Extra Thick claims that do not quantify the thickness 
  Lightly Powdered claims 
 
  Natural rubber latex gloves that do not include the latex "Caution" statement required by 
21 CFR 801.437.  These gloves are misbranded under section 502(a) because the labeling 
fails to reveal important information about the use of the product as required by section 
201(n). 
 
  Gloves that are not labeled with the name of the manufacturer or distributor are 
misbranded according to section 502(b). 
 
  Disposable gloves that are not labeled with a statement "For single use only" are 
misbranded according to section 502(f)(1) for failure to have adequate directions for use.  
 
  Gloves that do not meet applicable registration and listing requirements are misbranded 
according to section 502(o). 
 
Disposition of Adulterated or Misbranded gloves 
 
If any lots of medical gloves are found to be adulterated or misbranded, the manufacturer or 
importer of record may request to recondition the gloves to bring them into compliance (see 
21 CFR 800.20(d)).  
  
The importer of record should advise the FDA District Office that initiated the detention of 
the firm's plans to bring the product into compliance.  If the gloves cannot be brought into 
compliance, they cannot be marketed in the U.S. as medical gloves. 
 
79  Non-conforming medical gloves may be brought into conformance by: 
 
  reconditioning to correct the non-conformance, i.e., remove defective gloves, correct 
labeling deficiencies; or 
  reconditioning by relabeling, and subsequently distributing the gloves for non-
medical use, or non-FDA regulated use. 
 
A manufacturer/importer that chooses to recondition the product should request and obtain 
permission from the responsible FDA District Office. 
 
The importer of record may also request permission to recondition a commingled shipment 
that has failed FDA analysis by testing each lot or size in the shipment to identify whether 
some lots or sizes meet the specified acceptable quality levels.  Because the original analysis 
provides an appearance of adulteration, FDA will need greater assurance that the 
reconditioned gloves are not adulterated.  The importer should consult with the FDA District 
Office to obtain the appropriate sampling plan.  Only those lots/sizes that are shown to be in 
compliance, subject to verification testing by FDA, can be released for distribution in the 
U.S. 
 
If nonconforming medical gloves cannot be reconditioned, the medical gloves should be 
  re-exported to the country of manufacture or to a country where the gloves would 
meet local laws, or 
  destroyed, usually via landfill. 
 
DETENTION 
 
Detention 
 
Detention is the action that FDA takes against imported medical devices that do not comply 
with the laws that FDA administers (21 CFR 800.55)).  FDA may detain imported medical 
devices whenever physical examination or testing of a medical device, or examination of 
medical device labeling and labeling claims by FDA show that the medical device violates 
FDA laws.  The importer of record may file an appeal requesting an informal hearing.  A 
presiding FDA officer will affirm or revoke the detention.  Detained devices are either 
released if brought into compliance or refused entry if not brought into compliance.   
 
Detention Without Physical Examination  
 
Detention Without Physical Examination (DWPE) is the act by FDA of detaining the entry of 
a specified article, usually from a specific supplier, and occasionally from all suppliers from 
a specific country, without physical examination or testing.  DWPE differs from general 
administrative detention in that it is imposed based on the previous violative history of an 
imported medical device being offered for entry into the U.S.  DWPE does not occur as a 
result of a violative analysis or evaluation of the present entry found by FDA.  DWPE is an 
action used for repeat violations or violators.  DWPE essentially places the responsibility for 
80  determining quality and compliance with the law upon the U.S. importer or broker, and 
indirectly upon the foreign supplier (or sometimes a country).  DWPE is generally based on 
information regarding the past violative history of the medical device and/or other 
information indicating that the medical device may be violative.   
 
DWPE actions are implemented through the issuance of FDA Import Alerts.  A list of 
medical glove related FDA Import Alerts is provided below: 
 
IMPORT ALERTS FOR MEDICAL GLOVES 
 
There are currently several import alerts under which medical gloves are commonly refused 
entry.  Import alerts provide the reason for the alert and provide information on how to be 
removed from the alert: 
 
  Import Alert #80-04, Surveillance and Detention without Physical Examination of 
Surgeons and/or Patient Examination Gloves.  
http://www.fda.gov/ora/fiars/ora_import_ia8004.html  
 
Manufacturers/shippers placed on this alert have had at least one previous failure 
of their gloves to pass an FDA analysis.  This import alert consists of three 
increasingly more stringent levels of detention for manufacturers/shippers who 
repeatedly attempt to import adulterated gloves (Recidivist Firms). 
 
  Import Alert #89-04, Detention without Physical Examination of Devices that have 
not met Device GMPs.  
http://www.fda.gov/ora/fiars/ora_import_ia8904.html 
 
Manufacturers/shippers placed on this alert have had a violative FDA inspection 
and are not manufacturing in accordance with Quality System regulation.  
Manufacturers may be removed from the alert after an FDA inspection has 
verified corrective action. 
 
  Import Alert #89-08, Detention without Physical Examination of Class III Medical 
Devices Without Approved PMAs/IDEs or Other Devices Not Found Substantially 
Equivalent.  
http://www.fda.gov/ora/fiars/ora_import_ia8908.html 
 
Manufacturers/shippers placed on this alert do not have a cleared 510(k) for their 
gloves.  Manufacturers may have their gloves removed from the alert after they 
receive a 510(k) marketing clearance letter for the specific glove type (powdered, 
powder-free, vinyl, etc.).  
 
Importers may contact FDA near the port of entry and speak to the import operations staff 
regarding their entry.  Callers should have their entry numbers available for reference.   
 
FDA Field Offices 
  http://www.fda.gov/ora/inspect_ref/iom/iomoradir.html 
81   
More information regarding DWPE of gloves, including information regarding removal from 
DWPE, may be found in the FDA guidance, Surveillance and Detention Without Physical 
Examination of Surgeons and/or Patient Examination Gloves. 1  
 
 
                                                           
1 At the time this guidance was issued, the guidance on Surveillance and Detention Without Physical 
Examination of Surgeons and/or Patient Examination Gloves was in draft status. 
82  APPENDIX A - SUGGESTED GLOVE TESTING APPARATUS 
  
 
83   
84  10  VOLUNTARY STANDARDS 
 
INTRODUCTION ............................................................................................................... 85 
FDA-RECOGNIZED CONSENSUS STANDARDS ......................................................... 85 
OTHER CONSENSUS STANDARDS............................................................................... 86 
 
INTRODUCTION  
 
Conformance with recognized consensus standards can help provide a reasonable assurance 
of safety and/or effectiveness for many aspects of medical devices.  Conformance to 
consensus standards is voluntary and may be used to demonstrate performance or safety of a 
device.   
 
FDA-RECOGNIZED CONSENSUS STANDARDS 
 
Conformance with consensus standards will help establish the equivalence of a new glove to 
a legally marketed predicate glove in a Premarket Notification 510(k) submission.  If a 
person elects to use a standard recognized by FDA to meet a premarket submission 
requirement (or other requirement under the Act to which such standard is applicable), the 
person must provide a declaration of conformity to the FDA that certifies the device is in 
conformity with the standard (section 514(c)(1)(B) of the Act (21 USC 360d(c)(1)(B)). At 
any time, FDA may request the data or information relied on by the person to make a 
declaration of conformity (section 514(c)(3)(B)). A person making a declaration of 
conformity must maintain the data and information demonstrating conformity for a period of 
two years after the date of the classification or approval of the device by FDA or a period 
equal to the expected design life of the device, whichever is longer (514(c)(3)(C)).  
 
The manufacturer should submit the declaration of conformity in the Abbreviated 510(k) 
method. Consensus standards may also be used in the Traditional 510(k) method to help 
establish equivalence. See FDA guidances The New 510(k) Paradigm - Alternate 
Approaches to Demonstrating Substantial Equivalence in Premarket Notifications 
(http://www.fda.gov/cdrh/ode/parad510.html) and  Use of Standards in Substantial 
Equivalence Determinations (http://www.fda.gov/cdrh/ode/guidance/1131.html  for 
additional information on the use of consensus standards in 510(k) submissions. 
 
Information on FDAs standard program, including a database of FDA-recognized standards, 
can be found on the following website: 
 
CDRH Standards Program 
http://www.fda.gov/cdrh/stdsprog.html 
 
At this time FDA recognizes the following standards: 
 
85  Patient Examination Gloves 
 
ASTM  D5151  Standard Test Method for Detection of Holes in Medical Gloves 
Standard Specification for Nitrile Examination Gloves for 
ASTM  D6319 
Medical Application 
ASTM  D6124  Standard Test Method for Residual Powder on Medical Gloves 
Standard Specification for Poly(vinyl chloride) Gloves for 
ASTM  D5250 
Medical Application 
ASTM  D3578  Standard Specification for Rubber Examination Gloves 
ASTM  D3772  Standard Specification for Rubber Finger Cots 
 
 
Surgeons Gloves 
 
ASTM  D5151  Standard Test Method for Detection of Holes in Medical Gloves 
ASTM  D6124  Standard Test Method for Residual Powder on Medical Gloves 
ASTM  D3577  Standard Specification for Rubber Surgical Gloves 
 
 
Test Methods 
 
Standard Test Method for the Analysis of Aqueous Extractable 
ASTM  D5712  Protein in Natural Rubber and Its Products Using the Modified 
Lowry Method 
Standard Test Method for the Immunological Measurement of 
ASTM  D6499 
Antigenic Protein in Natural Rubber and Its Products 
ASTM  D5151  Standard Test Method for Detection of Holes in Medical Gloves 
ASTM  D6124  Standard Test Method for Residual Powder on Medical Gloves 
 
 
You can find current FDA-recognized standards in the CDRH standards database at 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/Search.cfm  
 
OTHER CONSENSUS STANDARDS  
 
In addition to FDA-recognized standards, manufacturers may use other consensus standards.  
As discussed earlier, under the Act, only FDA-recognized standards are those for which you 
may submit a declaration of conformity in order to meet a premarket requirement; however, 
you may find other consensus standards that have not been recognized by FDA useful.  
Below is a list of some of the standards applicable to medical gloves.   
 
86  Glove Standards 
 
ANSI/ADA76  Non-sterile latex gloves for dentistry. 
ADA Spec No. 102 Non-sterile nitrile gloves for dentistry. 
ASTM D5250  Standard specification for poly(vinyl chloride) gloves for medical 
application. 
ASTM draft  Standard specification for nitrile examination gloves for medical 
application. 
ISO10282  Single-use surgical rubber gloves-Specification. 
ISO11193  Single-use rubber examination gloves-Specification. 
AS/NZS 4011  Single-use examination glovesspecification. 
EN 455-1  Medical gloves for single use. Part 1. Specification for freedom from 
holes. 
EN 455-2  Medical gloves for single use. Part 2. Specification for physical 
properties. 
CAN 20.27-M91  Sterile or non-sterile medical examination gloves for single use. 
MS1155  Malaysian standard for rubber examination glove. 
JIS T 9107  Japanese Industrial Standard. Surgical gloves. 
 
 
Test Standards 
 
ASTM D412  Test methods for vulcanized rubber and thermoplastic rubbers and 
thermoplastic elastomerstension. 
ASTM D573  Test method for rubberdeterioration in an air oven. 
ASTM D3767  Practice for Rubbermeasurement of dimensions. 
ISO 2859   Sampling procedures and tables for inspection by attributes. 
ISO 37-94  Method for determination of tensile stress-strain properties (to determine 
the force at break) 
ISO 188  Heat resistance and accelerated aging tests. 
ISO 4648  Physical testing of rubber. Methods for the determination of dimensions of 
test pieces and products for test purpose. 
 
 
Expiration Dating 
 
ASTM D7160  Standard Practice for Determination of Expiration Dating for Medical 
Gloves  
ASTM D7161  Standard Practice for Determination of Real Time Expiration Dating of 
Mature Medical Gloves Stored Under Typical Warehouse Conditions 
 
 
Standard Organizations 
 
ADA  American Dental Association 
ANSI  American National Standards Institute 
87  ASTM  ASTM International 
CAN  National Standard of Canada 
EN  European Standard 
ISO  International Standard 
 
 
 
 
Each manufacturer that distributes patient examination or surgeon's gloves in the U.S. should 
have in its files at the manufacturing site an original copy of each pertinent standard 
referenced by the manufacturer's Quality System device master record(s) and/or 510(k) 
submission(s).  During an inspection, the FDA investigator may ask to see a copy of each 
referenced standard and any data demonstrating that the gloves conform to the standard. 
 
You may purchase standards from the following organizations.  
 
ANSI  ASTM International  
11 West 42nd Street  100 Barr Harbor Drive, 
New York, New York 10036   West Conshohocken, PA19428-2959  
Phone: 212-642-4900  Phone: (610) 832-9585  
Fax: 212-398-0023  Fax: (610) 832-9555 
http://www.ansi.org/    http://www.astm.org  
   
 
 
 
88