Contains Nonbinding Recommendations 
 
Guidance for Industry and FDA 
Staff 
Surveillance and Detention 
Without Physical Examination of 
Surgeons and/or Patient 
Examination Gloves 
 
Document issued on: July 11, 2008  
 
 
 
The draft of this document was issued on July 26, 2000 
 
For questions regarding this document contact Diane Goldsberry at 240-276-0115 or by email 
at diane.goldsberry@fda.hhs.gov. 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
General Hospital Devices Branch 
Division of Enforcement A 
Office of Compliance 
 
 
  Contains Nonbinding Recommendations 
 
 
Preface 
 
 
Public Comment 
 
 
Written comments and suggestions may be submitted at any time for Agency consideration to 
the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, 
Room 1061, (HFA-305), Rockville, MD, 20852.  Alternatively, electronic comments may be 
submitted to http://www.regulations.gov.  When submitting comments, please refer to Docket 
No. 00D-1141.  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 at: 
http://www.fda.gov/cdrh/comp/guidance/1141.pdf.  You may also send an e-mail request to 
dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 
240-276-3151 to receive a hard copy.  Please use the document number 1141 to identify the 
guidance you are requesting. 
 
  ii Contains Nonbinding Recommendations 
 
 
Guidance for Industry and FDA Staff 
 
Surveillance and Detention Without Physical 
Examination of Surgeons and/or Patient 
Examination Gloves 
 
 
 
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 
Health care providers, professionals, and others use surgeons and/or patient examination gloves 
(subsequently referred to as medical gloves in this document) as a barrier against the 
transmission of blood- and fluid-borne pathogens.  Because medical glove defects, such as holes, 
can compromise the effectiveness of the glove barrier and pose a potentially significant hazard to 
the health of users and their patients, FDA samples medicals gloves and performs water leak 
testing as described in Title 21, Code of Federal Regulation (CFR), Part 800.20.    
FDAs Center for Devices and Radiological Health (CDRH) is aware from its import records that 
some foreign manufacturers and shippers repeatedly attempt to import medical gloves that fail 
water leak testing (i.e., they do not meet the acceptable quality criteria defined in 21 CFR 
 800.20, based on the number of defective medical gloves in the samples).  To address the issue, 
FDA proposed a strategy for import surveillance and detention in the draft guidance made 
available on July 26, 2000. FDA is making available this final guidance document to provide 
guidance to FDA staff and industry, regarding FDAs strategy for addressing further imports of 
  1 Contains Nonbinding Recommendations 
 
 
medical gloves from manufacturers/shippers1 whose medical gloves have failed to meet FDAs 
minimum acceptable quality criteria.   
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.  
 
The Least Burdensome Approach 
We believe we should consider the least burdensome approach in all areas of medical device 
regulation.  This guidance reflects our careful review of the relevant scientific and legal 
requirements and what we believe is the least burdensome way for you to comply with those 
requirements.  However, if you believe that an alternative approach would be less burdensome, 
please contact us so we can consider your point of view.  You may send your written comments to 
the contact person listed in the preface to this guidance or to the CDRH Ombudsman.  
Comprehensive information on CDRH's Ombudsman, including ways to contact him, can be 
found on the Internet at http://www.fda.gov/cdrh/ombudsman/.  
 
Legal Basis for Denying Admission of Medical Gloves  
FDA may refuse admission of medical gloves into the United States under section 801(a)(3) of 
the Federal Food, Drug, and Cosmetic Act (the Act) if it appears from examination that they are 
adulterated or misbranded [21 U.S.C. 381(a)(3)]. 
FDA specifically defines sampling plans, a leak test method, and adulteration criteria for medical 
gloves in 21 CFR  800.20.  If FDA determines that a sampled shipment of medical gloves 
contains an unacceptable level of defects, as described in 21 CFR  800.20, then the shipment 
appears to be adulterated under section 501(c) of the Act [21 U.S.C. 351(c)], which defines a 
device as adulterated if its quality falls below that which it purports or is represented to possess.   
In addition, repeated shipments of adulterated medical gloves may present the appearance that 
the medical gloves are not manufactured in conformance with the Quality System regulation, 
Title 21, Code of Federal Regulations (CFR) Part 820, which is promulgated under section 
520(f) of the Act.  When a device appears to be in nonconformance with section 520(f) of the 
Act, the devices may be refused admission to the United States not only under section 801(a)(3) 
of the Act [21 U.S.C. 381(a)(3)], but also under section 801(a)(1) [21 U.S.C. 381(a)(1)], which 
authorizes refusal of admission, If it appears from the examination of such samples or otherwise 
                                                           
1 In this guidance, the term manufacturer and shipper refer to an entity whose name and address will be listed on the Import 
Alert as part of the information to identify the medical gloves that are subject to detention without physical examination because 
of an appearance of adulteration.  As used in this guidance, the term firm refers to an entity providing information to the 
agency to rebut the appearance of adulteration applicable to particular medical gloves.  This might be the manufacturer/shipper, 
importer, distributor or other entity. 
  2 Contains Nonbinding Recommendations 
 
 
that ... the methods used in, or the facilities or controls used for, the manufacture, packing, 
storage, or installation of the device do not conform to the requirements of section 520(f).  
Surveillance and Placement on Import Alert #80-04  
FDA field offices may detain, without physical examination, all shipments of medical gloves 
from manufacturers/shippers listed on FDAs Import Alert #80-04, Attachments A and B. 
Surveillance sampling of medical gloves from manufacturers/shippers that do not appear on 
Attachments A and B of Import Alert #80-04 should be performed according to the latest import 
guidance.  (For information regarding sampling, see the Sampling section of this document on 
page 11.) 
Because the presence of defects in medical gloves may present a possible potentially significant 
health hazard, one (1) violative sample may be sufficient to recommend detention without 
physical examination, as described in Chapter 9, Section 6 of the FDA Regulatory Procedures 
Manual  2008 (Import Operations and Actions; Detention without Physical Examination 
(DWPE)).  Therefore, in addition to detaining the violative shipment, the FDA field office at the 
port of entry should also submit a recommendation for detention of future shipments without 
physical examination to DIOP at HFC-170.  
Medical gloves from identified manufacturers/shippers should be placed on Import Alert #80-04 
under the regulatory classification for two categories of gloves only, "surgeons gloves" and 
"patient examination gloves."  Specific attributes, types/styles of medical gloves, such as color, 
powdered, powder-free, vinyl, latex, nitrile, etc., are not considered separate categories for the 
purposes of Import Alert #80-04 and should not be referenced in a recommendation for 
detention.  DIOP should review the recommendation to ensure the evidence supports detention 
without physical examination in accordance with the Act, and that such detention is consistent 
with the policy expressed in this guidance.  
While a manufacturer/shipper is listed on the Import Alert #80-04, any subsequent shipments of 
medical gloves in the category listed on the alert (surgeons gloves or patient examination 
gloves) from the same manufacturer/shipper may be detained without physical examination, 
including types, styles, or brands of medical gloves within the category that were not specifically 
found violative by testing. 
Purpose of Import Strategy
 
This guidance provides a risk-based decision process for managing the Agencys available 
resources for medical gloves.  FDAs strategy will manage the large volume of medical glove 
imports while allowing adequate opportunities for firms to demonstrate that the medical gloves 
offered for import conform to FDAs acceptable quality criteria in 21 CFR 800.20.  Accordingly, 
FDA has devised a risk-based, tiered process for placing medical gloves from identified 
manufacturers/shippers on Import Alert #80-04, for releasing individual shipments, and for 
removing medical gloves from the identified manufacturers/shippers from import alert.   
  3 Contains Nonbinding Recommendations 
 
 
Import Strategy 
This guidance document describes three levels of import surveillance and detention for medical 
gloves from manufacturers/shippers who have offered for import to the United States medical 
gloves that do not meet FDAs acceptable quality criteria that appears in 21 CFR  800.20, as 
evidenced by failure of FDA or independent private laboratory water leak testing occurring 
within a manufacturers/shippers Import Surveillance Cycle (Cycle).  A manufacturer/shipper 
Cycle begins on the date that it is placed on Level 1 Detention and ends when 24 months have 
elapsed since the initiation of the Cycle, unless the medical gloves from the manufacturer/shipper 
are placed on Level 3 detention, as described below in this guidance document.   
For each level, the guidance explains the criteria for that level, the actions the agency may take 
regarding import detention and refusal of admission, and what the agency will accept as evidence 
to demonstrate that the medical gloves being offered for import meet FDAs minimum 
acceptable quality criteria.  
Determining the Import Detention Level 
Routine examination of imports of medical gloves is conducted in accordance with 21 CFR 
 800.20. When such an examination reveals that a shipment of medical gloves is defective, 
FDA's enforcement strategy for addressing that shipment and future shipments of similar 
medical gloves from the same manufacturer/shipper will directly relate to the 
manufacturer/shippers import history.  That history will determine which of the three levels of 
detention is appropriate.    
The process used to make this determination is represented graphically in the flow chart provided 
on page 13.  Each stage of the process is cross-referenced with the corresponding flow chart 
decision, action, and outcome boxes in the discussion below.  
Level 1 Detention 
Criteria for Level 1 Detention (Flow Chart Decision Box D1): 
When DIOP receives a recommendation for detention, they should review the 
manufacturer/shippers import history to determine whether:  
  The manufacturer/shipper is currently listed on Import Alert #80-04, 
or 
  The manufacturer/shipper has previously been listed on Import Alert 
#80-04 within an ongoing cycle.   
If it is determined that neither of these conditions apply, then Level 1 
detention is appropriate. If either condition is applicable, see the Criteria 
for Level 2 Detention and the Criteria for Level 3 Detention sections 
below. 
  4 Contains Nonbinding Recommendations 
 
 
Placement on Level 1 Detention   (Flow Chart Action Box L1): 
If  DIOP  determines that the manufacturer/shipper has not been listed previously on Import 
Alert #80-04 during an ongoing Cycle, and that the recommendation supports detention under 
the Act due to the appearance of a violation, the manufacturer/shipper should be listed on 
Attachment A of Import Alert #80-04 with a single asterisk ("*") along with the date of listing.  
In this manner, the date on which the medical gloves from that manufacturer/shipper are placed 
on Level 1 detention will initiate the firms Cycle.   
A firm may dispel the appearance of adulteration and obtain admission of subsequent individual 
shipments of medical gloves listed on the import alert by presenting evidence to the FDA field 
office at the port of entry that the individual shipments are not adulterated.  Evidence may 
include sample testing performed by an independent private laboratory in the United States. The 
testing performed should follow the sampling plan and test methods in the current regulation, 21 
CFR  800.20.  For further information on how to submit private laboratory test results to FDA, 
refer to the Private Laboratory Guidance, found at Volume III, Section 7 of the ORA Laboratory 
Manual, available at http://www.fda.gov/ora/science_ref/lm/default.htm. 
 
Removal from Level 1 Detention:  (Flow Chart Decision Box D4) 
To obtain removal of a manufacturer/shippers medical gloves from Level 1 detention under this 
guidance, the firm should provide documentation to DIOP that contains sufficient evidence to 
show that imported medical gloves from the identified manufacturer/shipper consistently meet 
FDAs acceptable quality criteria.  Evidence sufficient for removal of a manufacturer/shippers 
medical gloves from Level 1 detention will generally consist of independent private laboratory 
analyses, using FDAs sampling plans and test methods, showing that a minimum of five 
consecutive surgeons glove or patient examination glove shipments meet the FDA acceptable 
quality criteria.  For further information on removal from detention refer to the Request for 
Release from Detention Without Physical Examination section on page 10 of this document. 
Important Note: (Flow Chart Outcome Box O1) 
Even when a manufacturer/shippers medical gloves have been removed from 
Level 1 detention, if another shipment of medical gloves from the same 
manufacturer/shipper fails analysis during the remainder of the Cycle, FDA 
should consider the previous placement on Level 1 detention when making further 
decisions regarding detention of the manufacturer/shippers imports.  (See Level 
2 Detention below.) 
 
Level 2 Detention 
Criteria for Level 2 Detention:  (Flow Chart Decision Boxes D1, D2) 
  5 Contains Nonbinding Recommendations 
 
 
When DIOP receives a recommendation for detention, they should review the 
manufacturer/shippers import history.   If DIOP determines that there is an 
ongoing Cycle and:  
  the manufacturer/shipper was previously listed on Import Alert 
#80-04, Level 1 Detention, as discussed above (Criteria for Level 
1 Detention) during this Cycle but its surgeons gloves or patient 
examination gloves were removed from the import alert without 
advancing to Level 2 Detention,  or 
  the manufacturer/shipper is currently listed on Import Alert #80-
04, Level 1 Detention, and there is further evidence that its 
surgeons gloves or patient examination gloves are adulterated, 
such as a violative private laboratory (or FDA) analysis, then 
DIOP will notify CDRH.  CDRH and DIOP will both review the 
manufacturer/shippers import history to determine if the 
evidence supports placing surgeons glove or patient examination 
gloves from that manufacturer/shipper on Level 2 detention.  
 
Placement on Level 2 Detention:   (Flow Chart Action Box L2) 
If the DIOP/CDRH review determines the recommendation supports detention under the Act due 
to the appearance of a violation and that the criteria for Level 2 detention have been met, then the 
manufacturer/shippers name should be listed on Attachment A of Import Alert #80-04 with two 
asterisks ("**") and the date that its medical gloves were most recently placed on Level 1 
detention.  
At the same time, CDRH should notify the foreign manufacturer/shipper in writing about 
possible deficiencies in their manufacturing procedures and practices that may be affecting the 
quality of the medical gloves offered for import to the United States.  The letter should advise the 
foreign manufacturer/shipper that continued failure of its medical gloves to meet FDAs 
acceptable quality criteria may create an appearance that the manufacturer/shippers 
manufacturing process does not satisfy the Quality System requirements promulgated under 
section 520(f) of the Act.  Such an appearance would constitute the basis for detention of imports 
under section 801(a)(1) until FDA receives satisfactory evidence of compliance with the Quality 
System requirements.  Manufacturers will be advised that they should review their 
manufacturing procedures and practices to assure they are in accordance with the Quality System 
regulation (21 CFR Part 820).  If the review shows that corrections are necessary to ensure 
medical gloves of acceptable quality, then such corrections should be made prior to offering 
further shipments of medical gloves for entry to the United States.  A copy of the Quality System 
regulation should be attached to the letter for the manufacturer/shippers information. 
A firm may dispel the appearance of adulteration and obtain admission of subsequent individual 
shipments of medical gloves from a manufacturer/shipper listed on Import Alert #80-04, Level 2 
detention, by presenting evidence to the FDA district office at the port of entry that an individual 
  6 Contains Nonbinding Recommendations 
 
 
shipment is not adulterated.  Evidence may include sample testing performed by an independent 
private laboratory in the United States. 
Removal from Level 2 Detention:  (Flow Chart Decision Box D3) 
To obtain removal of a manufacturer/shippers medical gloves from Level 2 detention under this 
guidance, a firm should provide documentation to DIOP that contains sufficient evidence to 
show that the imported medical gloves consistently meet FDAs acceptable quality criteria.  Due 
to FDAs increased concerns at Level 2 regarding the ability of the manufacturer/shippers 
medical gloves to meet the FDA criteria, FDA may need greater assurance than is needed for 
removal from Level 1 detention.  Evidence sufficient for removal of a manufacturer/shippers 
medical gloves from Level 2 detention will generally consist of independent private laboratory 
analyses, using FDAs sampling plans and test methods, showing that a minimum of ten 
consecutive medical gloves shipments meet the FDA acceptable quality criteria.  For further 
information on removal from detention refer to the Request for Release from Detention Without 
Physical Examination section on page 10 of this document. 
Important Note:   (Flow Chart Outcome Box O1) 
After DIOP receives adequate evidence, FDA may remove the 
manufacturer/shippers medical gloves from Level 2 detention. However, if 
another shipment of medical gloves from this same manufacturer/shipper is found 
to be defective during the remainder of the Cycle, FDA should consider its history 
on Level 2 detention when making further decisions regarding detention of the 
manufacturer/shippers imports.  (See Level 3 Detention below.)   
 
Level 3 Detention  
Criteria for Level 3 Detention:  (Flow Chart Decision Boxes D1, D2) 
When DIOP receives a recommendation for detention, they should review 
the manufacturer/shippers import history.  If DIOP determines that there 
is an ongoing Cycle and:  
  the manufacturer/shipper was listed on Import Alert #80-04, Level 
2 Detention, during this Cycle but its surgeons or patient 
examination gloves were removed from the import alert without 
advancing to Level 3 Detention, or 
  the manufacturer/shipper is currently listed on Import Alert #80-
04, Level 2 Detention, and there is further evidence that its 
surgeons gloves or patient examination gloves are adulterated, 
such as a violative private laboratory (or FDA) analysis,  
  7 Contains Nonbinding Recommendations 
 
 
DIOP will notify CDRH.   CDRH and DIOP will both review the 
manufacturer/shippers import history to determine if the evidence supports 
Level 3 detention. 
Placement on Level 3 Detention:   (Flow Chart Action Box L3) 
If DIOPs review determines that the recommendation supports detention under the Act due to 
the appearance of a violation and that the Criteria for Level 3 Detention have been met, then the 
manufacturer/shipper should be listed temporarily on Attachment A of Import Alert #80-04 with 
three asterisks ("***") until CDRH completes its review of the supporting documents and other 
relevant information.  These documents may include, but are not limited to, results of FDA and 
private laboratory sample analysis, previous import history, and the status of the current Cycle. 
Firms attempting to import medical gloves that are in this temporary status may request entry of  
individual shipments based on independent private laboratory testing, conducted in accordance 
with 21 CFR  800.20, which indicates the shipment is of acceptable quality. 
Placement on Attachment B:   (Flow Chart Outcome Box O2) 
If the CDRH review finds that the supporting documents and other relevant information presents 
the appearance that the methods used in, or the facilities or controls used for, the manufacture, 
packing, or storage of the device at the manufacturer/shippers facility do not conform to the 
requirements of section 520(f), then future shipments of the medical gloves manufactured at that 
facility may be refused admission pursuant to section 801(a)(1)).  CDRH will then notify DIOP 
that they should list that manufacturer/shippers facility on Attachment B of Import Alert #80-04.  
At the same time, CDRH should notify the foreign manufacturer/shipper in writing  that there is 
an appearance of nonconformance to the requirements of section 520(f), and that future 
shipments of the manufacturer/shippers medical gloves may be refused admission in accordance 
with section 801(a)(1) until the manufacturer/shipper provides adequate evidence to rebut this 
appearance.  
Removal from Level 3 Detention (Attachment B):  
Test results showing that individual shipments of medical gloves meets FDAs minimum 
acceptable quality criteria generally will not be sufficient for release of individual shipments of 
medical gloves listed in Level 3 Detention (Attachment B)  nor will they be sufficient for 
removal from Level 3 detention. A history of repeated shipments of defective medical gloves can 
present the appearance of nonconformance with good manufacturing practices [section 520(f)].  
Evidence showing that individual shipments of medical gloves are of acceptable quality, and 
therefore, not adulterated under section 501(c), may not be adequate to dispel the appearance of 
nonconformance with 520(f) because the medical gloves may have been produced under a 
manufacturing system that does not conform to good manufacturing practices.  The appearance 
of failure to comply with the requirements of 520(f) provides an independent basis for refusal of 
admission under section 801(a)(1).   
  8 Contains Nonbinding Recommendations 
 
 
To correct the appearance of violations underlying detention without physical examination for 
medical gloves on Level 3 detention, a manufacturer should assess its manufacturing system and 
correct any systemic problems that underlie the apparent nonconformance with good 
manufacturing practices.   It should demonstrate to FDA/CDRH that the medical gloves 
produced at the facility listed on Attachment B are manufactured in accordance with the Quality 
System regulation.  Such evidence should include a FDA on-site inspection of the manufacturing 
facilities that indicate conformance with the Quality System regulation, or a written certification 
of conformance with the Quality System regulation provided by the manufacturer/shipper 
together with the results of an independent audit performed by a qualified third party. 
After the manufacturer/shipper demonstrates to CDRH that the apparent systemic manufacturing 
problems have been corrected and that it is complying with section 520(f), CDRH will request 
that DIOP remove the manufacturer/shippers medical gloves from Level 3, Attachment B. The 
manufacturer/shippers medical gloves then will be placed on Attachment A of Import Alert #80-
04 with the statement: "[Firm name] was moved from Attachment B to Attachment A on [date], 
as the result of an establishment inspection of the firm.  Products from this firm remain subject to 
DWPE. Districts should immediately report violative private laboratory results to DIOP 
Operations and Policy Branch" to indicate they have been removed from Level 3, Attachment B, 
but are now in an interim status pending submission of additional evidence to correct the 
appearance of adulteration under section 501(c) caused by the past violative shipments. While 
the manufacturer/shippers medical gloves are in this interim detention status, FDA may detain 
shipments of medical gloves without physical examination.  However, firms may obtain entry of 
individual shipments by presenting evidence to the FDA field office at the port of entry to rebut 
the appearance of (501(c)) adulteration, such as independent private laboratory testing of 
individual shipments to demonstrate that the surgeons and/or patient examination gloves meet 
FDAs acceptable quality criteria.  
With sufficient evidence, the manufacturer/shippers products may be removed from this interim 
status. Evidence sufficient for removal of a manufacturer/shippers medical gloves from this 
interim detention status will generally consist of independent private laboratory analyses using 
FDAs sampling plans and test methods, showing that a minimum of five consecutive surgeons 
or patient examination glove shipments meet the FDA acceptable quality criteria.  Removal from 
the interim detention status, subsequent to removal from Level 3, Attachment B, based on an 
acceptable FDA or third party inspection, ends the manufacturer/shipper current Cycle. At this 
point, a firm may request removal of its surgeons or patient examination gloves from the listing 
on Import Alert #80-04 (and termination of the Cycle) as described in the Request for Release 
from Detention Without Physical Examination section on page 10 of this document.  
If a manufacturer/shippers medical gloves are currently on the Import Alert #80-04 in 
interim status and FDA receives further evidence of adulteration, such as a violative analysis 
from an independent private laboratory (or FDA), the field office at the port of entry should 
make a recommendation to DIOP for detention.  If the DIOP review determines that the 
recommendation supports detention under the Act due to the appearance of a violation, the 
manufacturer/shipper should be listed on Attachment A of Import Alert #80-04 with a single 
asterisk ("*") along with the date of listing.  In this manner, the date on which the 
manufacturer/shippers surgeonsor patient examination gloves are placed on Level 1 
detention will initiate a new import surveillance Cycle.  Likewise, if a Cycle has ended and a 
  9 Contains Nonbinding Recommendations 
 
 
manufacturer/shippers surgeons or patient examination gloves are removed from the Import 
Alert, but a future shipment of surgeons or patient examination gloves from the same 
manufacture/shipper is tested and found to be defective by FDA or an independent private 
laboratory, the manufacture/shippers surgeons or patient examination gloves may again be 
placed on Level 1, beginning a new Cycle.  Once a new Cycle has begun, the import history 
of the manufacturer/shippers surgeons or patient examination gloves prior to the beginning 
of the new Cycle should not be taken into consideration for purposes of determining the 
import detention level. 
Request for Reconsideration of Detention Level 
A firm who believes that its medical gloves have been inappropriately placed on Level 2 or 
Level 3 detention may submit evidence to CDRH to rebut this placement.2  For example, the 
firm might present evidence that results of analyses indicating defects in its medical gloves were 
actually caused by type 1 sampling errors.3 It might also present evidence that previous defective 
shipments were found during a previously concluded Cycle, so that a new shipment of defective 
medical gloves should result at most in placement on Level 1 detention and initiation of a new 
Cycle.  CDRH will review any such information submitted, in conjunction with the documents 
relating to the analyses of the medical gloves in question and evaluate which level of detention, 
if any, is appropriate.  
Request for Release from Detention Without Physical 
Examination  
In order for the manufacturer/shippers medical gloves to be removed from Attachment A of 
Import Alert #80-04,4 FDA should be provided with satisfactory results of sample analyses for a 
number of consecutive shipments sufficient to demonstrate compliance with FDA requirements. 
The documentation should consist of  
  documentation, including FDA entry numbers showing the FDA release of a number of 
consecutive entries of the manufacturers devices sufficient to demonstrate compliance 
with FDA requirements, (see Removal from Level 1 Detention Without Physical 
Examination and Removal from Level 2 Detention Without Physical Examination) 
and  
  test records (analytical worksheets) from independent qualified U.S. testing laboratories 
using the FDA analytical worksheet form FDA 431 or equivalent. Testing performed at 
the manufacturing facility or by private laboratories in the country of origin may not be 
                                                           
2 Firms who believe their medical gloves have been inappropriately placed on Level 1 Detention should contact 
DIOP to attempt to rebut this placement.  
3 Type 1 sampling error is the probability that a sampling plan for attributes will reject a lot when true percent 
defective is equal to or less than (<) the Acceptable Quality Level (AQL), where the AQL is equal (=) to the percent 
defective that a sampling plan for attributes will accept with probability equal (=) to 0.95. 
4 Removal of medical gloves from Level 3, Attachment B, which results in the gloves being returned to listing on 
Attachment A, is addressed above at pages 8-9. 
  10 Contains Nonbinding Recommendations 
 
 
acceptable due to the potential for rapid degradation of medical gloves during shipment 
to the United States.  
Firms may submit the appropriate documentation with a request for their medical gloves to be 
removed from the Import Alert and from Detention without Physical Examination to the 
following office in FDA: 
Division of Import Operations and Policy (DIOP) 
5600 Fishers Lane (HFC-170) 
Rockville, Maryland 20857 USA 
Phone: 301-443-6553 Fax: 301-594-0413 
If FDA agrees that the results of sample analysis or other evidence submitted demonstrates 
compliance of the manufacturer/shipper and medical gloves, then the manufacturer/shippers 
medical gloves will be removed from the Import Alert and no longer subject to Detention 
 
without Physical Examination. 
Sampling 
Sampling should be conducted according to the sampling plan in 21 CFR  800.20 and the most 
recent applicable sampling guidance documents, including Import Alert #80-04. 
Only one brand and type of glove (powdered latex, powder-free vinyl, etc.) should be included in 
a single test sample.   However, all sizes of that glove type should be represented in the sample 
collected to reflect the proportion of glove types in the shipment. Exact statistical representation 
is not necessary. If a sample is found violative, all sizes should be detained. 
If only one size, attempt to collect as many lot numbers as possible. For example, if during a 
random sample collection three lot numbers are observed, the sample should represent all of the 
lots as sub-samples within one sample. If the sample is found violative, all lots should be 
detained. 
When taking a sample of one type of a surgeons glove or patient examination glove from a 
shipment that includes numerous boxes/cartons of that type, FDA sample collectors should 
attempt to open several different cartons to obtain a representative sample. 
Further Information 
Questions or issues concerning science, science policy, sample collection, testing, preparation, or 
analytical methodology should be forwarded to the Division of Field Science at (301) 827-7605 
or (301) 827-7606. 
Questions concerning 21 CFR  800.20, surgeons and/or patient examination glove labeling, or 
other compliance issues should be forwarded to Center for Devices and Radiological Health, 
  11 Contains Nonbinding Recommendations 
 
 
Office of Compliance, Division of Enforcement A, General Hospital Devices Branch at (240) 
276-0115. 
 
  12 Contains Nonbinding Recommendations 
 
 
 
FLOW CHART OF DETENTION LEVEL DETERMINATION 
Input 
Recommendation for detention 
based on failure of sample 
No  Is there an 
ongoing detention 
Cycle? 
D1
Yes 
IA 80-04 Att. B 
Firm previously  Yes Lab analyses 
on Level 2 this       Level 3  not sufficient 
cycle?  for removal 
D2  L3 from Level 3  
O2
No 
  24    Yes 
months 
     Level 2  D5
expired?
L2 Cycle ends 
No  O3
No  Yes
Off detention list but cycle 
Pass 10 private 
continues. If another violative 
lab analyses? 
analysis found, begin at top 
of chart. 
Go to 
D3 O1
top of 
chart 
Yes
No  
L1 Pass 5 private lab 
Level 1  
Go to 
analyses (with no 
(start cycle) 
top of 
failures)?
D4 chart 
 
  13