This guidance was written prior to the February 27, 1997 implementation of FDA's 
Good Guidance Practices, GGP's. It does not create or confer rights for or on any person 
and does not operate to bind FDA or the public. An alternative approach may be used if 
such approach satisfies the requirements of the applicable statute, regulations, or both. 
This guidance will be up dated in the next revision to include the standard elemnt s of GGP 's .  Guidance on 
Premarket Notification [510(k)] Submissions 
for 
Surgical Gowns and Surgical Drapes 
Infection Control Devices Branch 
Division of General and Restorative Devices 
August, 1993  Preface 
This guidance was developed by the Infection Control Devices Branch, Division 
of General and Restorative Devices (DGRD), Office of Device Evaluation (ODE), 
Center for Devices and Radiological Health (CDRH), Food and Drug 
Administration (FDA). 
FDA regulates the introduction of medical devices into interstate commerce.  A 
person intending to market surgical gowns or surgical drapes must submit to 
FDA, and have cleared, a premarket notification [510(k)]  submission prior to 
its introduction into interstate commerce.  Regulations governing the general 
content and format of 510(k)  submissions are codified under 21 Code of Federal 
Regulations, Part 807.  These and other regulatory requirements pertaining to 
the marketing of a new medical device are discussed in guidance documents 
available from the CDRH Division of Small Manufacturers Assistance (DSMA). 
The intent of this guidance document is to provide 510(k)  applicants specific 
additional directions regarding information and data which should be submitted 
to FDA in a 510(k)  submission for surgical gowns and surgical drapes. 
A safe and effective barrier device to protect both the surgical patient and 
the operating room personnel from the transfer of microorganisms or body 
fluids during surgical procedures is important in preventing infections. 
Comprehensive, scientifically sound criteria for the evaluation of surgical 
gowns or surgical drapes is essential to help ensure that these devices are 
safe and effective for their intended use when used according to their 
labeling.  FDA recognizes the importance of providing applicants, and other 
interested parties, the agency's 510(k)  submission criteria for surgical gowns 
or surgical drapes in order to facilitate assembly of necessary data, to 
maintain consistency of review, and to provide for a more efficient regulatory 
process. 
The document expresses FDA's recommendations as of the date noted on the cover 
page.  There is ongoing research and debate with regard to the design and test 
methods for surgical gowns and surgical drapes.  Despite this state of flux, 
FDA finds it necessary at this time to document its 510(k)  submission criteria 
in order to expedite the availability of safe and effective surgical gowns and 
surgical drapes.  FDA expects that this document will stimulate and/or 
accelerate development of test methods and specific validation procedures by 
the scientific community and regulated industry.  The document is not static 
but will be periodically revised to keep it current with state of the art 
developments in this area.  Comments on the document are welcome and should be 
sent to the address noted on page 11.  CONTENTS 
I.  Introduction 
Page 
Scope  3 
Purpose  3 
Definitions  3 - 4  
Principles Regarding Presentation of Data  4 - 5  
Document Availability  5 
11.  Content and Organization of Information in a 510(k) 
Cover Letter  5  -  6 
Table of Contents  6 
Labels and Labeling  6 -  7 
1.  Proposed Labels and Labeling 
2.  Labeling Requirements 
3.  Packaging Labels 
Standards 
Device Description 
1.  Description of the device 
2.  Intended Use 
3.  Specifications for the device 
4.  Complete listing of all materials used 
Descriptive Comparison to a Legally Marketed Device 
Performance Data Supporting Substantial Equivalence 
1.  Biocompatibility 
2.  Comparative Claims 
3.  Unique Designs 
Sterility Information 
SMDA Requirements 
Contacts and Addresses 
Reviewer's Checklist  L.  Comparison Table 
111.  Premarket Notification for Kits 
A.  Kit Information  I.  Introduction 
A.  Scope 
This document establishes the 510(k)  review requirements for surgical 
gowns and surgical drapes. 
Exclus ions 
Surgical suits and dresses, commonly known as scrub suits, which are 
exempted in the surgical apparel classification regulation, will not be 
included in this Guidance.  Surgical masks, which are included in the 
classification regulation for surgical apparel, will be the subject of 
another guidance document. 
B.  Purpose 
This guidance is intended to: 
1.  assist persons (manufacturers, distributors, or import-ers) in 
organizing premarket notifications for surgical gowns and surgical 
drapes ; 
2.  achieve consistency in meeting the requirements and in the 
presentation of information; and 
3.  guide FDA review staff in conducting and documenting the review of 
premarket notifications. 
C.  Definitions 
1.  Surgical Gown: Described in 21 CF'R  $878.4040 as surgical apparel 
worn by operating room personnel during surgical procedures to 
protect both the surgical patient and the operating room personnel 
from transfer of microorganisms, body fluids, and particulate 
material. 
2.  Surgical Drape: Described in 21 CFR 5878.4370 as a device made of 
natural or synthetic materials intended to be used as a protective 
patient covering, such as to isolate a site of surgical incision 
from microbial and other contamination. 
3.  Intended Use: A statement of all conditions, purposes, uses for 
which such device is intended, including conditions, purposes, or 
uses for which it is recommended, prescribed, or suggested in its 
oral, written, printed or graphic advertising or uses for which 
the device is commonly used.  Conditions include: single use only, 
disposable, and reusable. 
4.  Sterility Assurance Level (SAL): A value indicating the 
probability of a survivor after a sterilization process. For 
example, an SAL of  is the probability of one in one million 
nonsterile units after exposure to a sterilization process.  5.  Abbreviations : 
AAMI  - Association for the Advancement of Medical Instrumentation 
AATCC - American Association of Textile Chemists and Colorfastness 
CPSC -  Consumer Products Safety Commission 
ASTM - American Society for Testing and Materials 
CER -  Code of Federal Regulations 
NFPA - National Fire Protection Association 
SMDA -  Safe Medical Devices Act of 1990 
DSMA - Division of Small Manufacturers Assistance 
ODE -  Office of Device Evaluation 
OC -  Office of Compliance 
D.  Principles Regarding Presentation of Data 
1.  Editorial Considerations:  The 510(k)  should be carefully edited 
as well as scientifically reviewed before it is submitted to FDA. 
It should be proofread to assure that all pages are properly 
indicated, consecutive, distinctly copied, and readable. 
2.  Abbreviations:  Standard abbreviations acceptable to a significant 
peer reviewed journal should be used wherever possible.  All other 
abbreviations should be identified at the beginning of each 
section in which they are used or in footnotes to tables and 
graphs. 
3.  Data Availability:  The document outlines typical circumstances of 
data review.  It is not possible to anticipate all situations that 
may require further FDA analyses.  Thus, submitters should be 
aware that they may be asked, at FDA's discretion, to submit 
additional data or to present data in another format or to provide 
more detailed explanations of the information submitted. 
Applicants should keep data used for the 510(k)  submission in a 
controlled and well- organized format.  This will allow the firm to 
expeditiously supply FDA with additional information or analysis 
if required.  Errors in data that are identified by the applicant 
after submission to FDA should be brought to FDA's attention 
immediately. 
4.  Tables and Gra~hs: Well-constructed tables are fundamental to the 
reporting and evaluation of data.  All tables should be clearly 
identified and captioned with symbols keyed to a footnote or 
accessible reference page that adequately indicates the nature of  the data. 
Graphs should supplement, not replace, data tables.  They should 
be of a quality acceptable to a significant peer reviewed 
scientific journal. 
5.  Published Literature:  Published methods or data referenced in 
study reports should be appended to the study report.  Reprints of 
other referenced published reports or data should be appended to 
the section in which they are referenced.  All referenced reports 
and data should be summarized including an explanation how it 
relates to the current submission. 
E.  Document Availability 
The following relevant FDA documents are available from DSMA at 
(800)638-2041 or (301) 443-6597: 
Tripartite Biocompatibility Guidance for Medical Devices 
ODE Blue Book Memorandum tkK90-1: 510 (k) Sterility Review 
Guidance 
Guidance on the Content of Premarket Notifications 
11.  Content and Organization of Information in a 510(k) 
A.  Cover Letter 
The submission shall have a cover letter providing the following 
information described in 5807.87 (Information required in a premarket 
notification submission): 
1.  the trade or proprietary name; 
2.  common names: Select the appropriate name from the following: 
a.  Nonsterile or sterile surgical drape 
b.  Surgical towel or operating room towel 
c.  Nonsterile or sterile surgical gowns 
3.  classification names:  Select the appropriate name from the 
following: 
a.  Surgical drape and drape accessories 
b.  Surgical apparel 
4.  the establishment registration number, if applicable, of the 
sponsor, owner or operator submitting the premarket notification;,  5.  the appropriate class, panel and procode from the following: 
Class :  II  
Panel :  79  
Procodes:  KKX  -  Surgical drapes 
FYA -  Surgical gowns 
FYC -  Isolation gown 
FPH -  Operating room gowns 
6.  a statement explaining the purpose of the submission (e.g., new 
device, significant modification of device previously found 
equivalent (new intended use, material, or manufacturing process, 
etc. ) 
For devices that are being modified, refer to 807.87(g)  for 
additional requirements.  The change may require some or all of 
the information needed for a new device.  Please supply the 
previous 510 (k) number(s),  if applicable. 
7.  a brief statement indicating the device is similar to.and/or 
different from other products of comparable type in commercial 
distribution: and 
8.  the name and phone number of a U.S. contact person, if available. 
B.  Table of Contents 
The 510(k)  shall include a table of contents noting section titles and 
pages.  Each section shall be separated and begin with a section 
contents page if the section consists of several parts. 
C.  Labels and Labeling 
1.  The submission should contain proposed labels, labeling, and 
advertisements sufficient to describe the device, its intended 
use, and the directions for use.  Labels include the information 
affixed directly to the device and its packaging. 
2.  The labeling must meet the requirements of 21 CFX Part 801 as it 
relates to a determination of intended use.  ODE will therefore 
concentrate on the following: 
Subpart A, $801.4 and s801.5, related to intended uses and 
adequate directions for use; and 
Subpart B, s801.109 and 5801.116, related to prescription devices 
and commonly known directions. 
Other portions of labeling requirements are deferred for review to 
CDRH/OC Promotion and Advertising Policy Staff.  3.  Labeling for surgical gowns and surgical drapes shall contain the 
following, as applicable : 
a.  the contents of the package, i.e., surgical gowns, isolation 
gowns, abdominal drapes or surgical drapes; 
b.  the size (S,M,L,XL)f or gowns or measurements for drapes; 
c.  quantity and the conditions of use, i.e., reusable, 
disposable/single use ; 
d.  for sterile, single use gowns and drapes, the word 
"Sterile", and the statement, "Unless Package is Opened or 
Damaged" ; 
e.  the manufacturer lot and batch numbers; 
f.  for gowns and/or drapes offered nonsterile and/or reusable 
to the end user, the label shall contain instructions on how 
to reprocess the device including laundering and 
sterilization information, the number of reprocessings the 
gown/drape can withstand and a system for keeping track of 
reuse cycles; and 
g.  any specific warning/caution statements, i.e., "Do not use 
near flammable anesthesia gases", or "Does not meet NFPA 
standards."  
D.  Standards 
Appropriate or relevant industry or regulatory standards which the gown 
or drape meets should be referenced, including the year of the standards 
publication. The applicant may certify that the device meets the stated 
standard.  The applicant then is obliged to meet the standard and 
maintain documentation of testing showing that the device meets the 
standard.  Certification of meeting a specific standard may reduce the 
data requirements for the 510(k)  submission. 
Listed below are some relevant standards used in determining the barrier 
performance and safe use of gowns and drapes; 
1.  NFPA Standards -  Standards for the Use of Inhalation Anesthetics 
2.  ASTM ES-21-1992, Standard Test Method for Resistance of Protective 
Clothing Materials to Synthetic Blood. 
3.  ASTM ES-22-1992, Test Method for Resistance of Protective Clothing 
Materials to Penetration by Bloodborne Pathogens Using Viral 
Penetration as a Test System. 
4.  ASTMD737-75, Air Permeability. 
5.  AATCC Test Method 127-1989, Water Resistance: Hydrostatic Pressure  Test (water resistance claims). 
6.  AATCC Test Method 61-1989, Colorfastness to Laundering, Home and 
Commercial: Accelerated. 
7.  ASTM D1424, Elemendorf Tear. 
8.  ASTM D1682, Grab Tensile/Elongation 
E.  Device Description 
The applicant must submit a complete description of the device, 
including all models, styles and variations. 
1.  Provide a description of the device in sufficient detail to 
facilitate the evaluation of the device (e.g., photographs, 
detailed drawings).  Drawings of surgical gowns should show 
barrier features and/or specifications in critical areas of the 
gown (e.g., cuffs and seams, the thoracic -region of the gown, and 
sleeve areas) . 
2.  Provide a clear description of the intended use(s)  of the device. 
3.  Provide the specifications for the device(s).  The applicant may 
refer to relevant standards. 
a.  Physical S~ecifications 
(1)  weave, thread count, weight per square yard or 
thickness, as applicable 
(2)  sizes (S ,M,L,XL) 
(3)  resistance to blood and liquid penetration 
(4)  resistance to tears and punctures 
(5)  features for safe use in the operating room 
environment, i.e.,lint free, free of toxic ingredients 
and nonfast dyes 
(6)  fire protection 
b.  Mechanical Specifications 
(1)  strength (tensile, grab, burst) 
(2)  durability -  number of times the device can be 
processed (laundered and sterilized) and meet 
specifications using the sterilization method 
indicated in the labeling  c.  Biological S~ecifications 
(1)  Materials and colors used in the finished gown/drape 
must be biocompatible in accordance with the 
Tripartite Biocompatibility Guidance or IS0 194. The 
materials must be biocompatible within the conditions 
of patient/user  exposure.  These devices are 
categorized under the guidance as External, Breached 
or Compromised Surface, Short-Term. 
4.  Provide a complete listing of all materials used in fabricating 
the device, i.e., colors, dyes, fabrics. 
F.  Descriptive Comparison to a Legally Marketed Device 
Identify a legally marketed device to which substantial equivalence is 
claimed. If possible, provide the 510(k)  numbers.  More than one device 
can be listed, but the device(s)  chosen should be as close in intended 
use and technology to the new device as possible.  Provide the 
information noted below to show how the new device is both similar to or 
different from the legally marketed device.  Side by side comparisons, 
whenever possible, are desirable (see Attachment 1).  Indicate how any 
differences may affect safety and effectiveness. 
1.  Provide labeling (labels, instructions for use, promotional 
material) for the legally marketed device(s)  to which substantial 
equivalence is claimed.  To facilitate comparison, also include 
clear photographs, or other representations of the legally 
marketed device(s),  unless the labeling has ample information. 
2.  Compare and contrast the intended use for the new device to the 
predicate. 
3.  Compare all materials used to fabricate the device.  The precise 
materials of the new device, and if possible, the predicate should 
be identified to the extent possible. 
4.  Compare physical, mechanical, and biological specifications and 
performance data. 
G.  Performance Data Supporting Substantial Equivalence 
In many cases descriptive data alone will be sufficient to establish 
equivalence.  However, comparisons of performance of the new device to a 
legally marketed device may be necessary.  When requested, provide the 
protocols and results of specified tests needed to establish 
equivalence.  If the stated test is a standard method that specifically 
addresses the performance criterion, then the applicant may reference 
the method and certify that the device will meet the criterion.  Data 
need not be submitted in this instance.  The studies should be well designed to meet the stated objectives.  This 
will include rigorous attention to: statistical elements (hypotheses, 
test statistic, analyses, sample size and sampling, power, etc), 
inclusion/exclusion criteria, controls, minimization of bias, test 
parameters (endpoints), follow up, evaluation criteria, etc.  Some of 
the above points may overlap.  Ample reference material exists on study 
design and methods upon which the applicant may rely if the method is 
not specified in the guidance (e.g., biocompatibility). 
The submission should provide test data which demonstrates that the 
surgical gown/drape is made of material that is an effective barrier for 
minimizing the passage of microorganisms between nonsterile and sterile 
areas. Provide the protocols and the results of specified tests that are 
needed to establish equivalence. 
1.  Biocompatibility 
Submit a certification that either (1) the identical materials 
have been used in other legally marketed devices used under the 
same use conditions, or (2) provide documentation attesting to the 
biocompatibility of the component materials in the finished 
product according to the 1987 Tripartite Biocompatibility Guidance 
for Medical Devices and/or 1992 draft IS0 194 standard (Biological 
testing of Medical and Dental Materials and Devices). 
Biocompatibility test data may be required for colors that are not 
listed in FDA regulations, or are not used in other legally 
marketed devices for a similar intended use. 
2.  Comparative Claims 
Additional data may be needed for comparative claims that are 
unique or not based upon a standard that the applicant has 
certified the device meets. 
3.  Unique Designs 
Additional data may be needed to support designs that are 
significantly different from traditional designs and are not 
encompassed by standards to which the applicant can reference 
H.  Sterility Information 
For a device sold sterile, provide the following information as detailed 
in the ODE Blue Book Memorandum tkK90-1. 
1.  Sterilization method that will be used. 
2.  A description of the method that will be used to validate the 
sterilization cycle, but not the validation data itself. 
Reference to a standard method (e.g., AAMI Radiation Standard) 
usually is sufficient.  3.  The sterility assurance level (SAL) for the device which the firm 
intends to meet.  An SAL of  is required for surgical drapes 
and surgical gowns which are to be used during surgical 
procedures. 
4.  A description of the packaging to maintain the device's sterility 
(this is not to include packaging integrity testing data). 
5.  If sterilization involves EtO, the maximum levels of residues of 
ethylene oxide, ethylene chlorohydrin, and ethylene glycol which 
remain on the device.  The levels should be consistent with the 
draft Federal Register Notice on EtO limits.' 
6.  The radiation dose, if radiation sterilization will be used, and 
if it has been determined.  Otherwise, amend the 510(k)  file at 
FDA when the dose has been determined. 
References 
1.  FDA Proposed Rule, 43 ER 27482 (June 23, 1978), Maximp Residue 
Limits for Ethylene Oxide, Ethylene Chlorohydrin, and Ethylene 
Glycol. 
I.  SMDA Requirements 
All persons submitting a 510 (k) must include either a summary of safety 
and effectiveness information in the 510 (k) upon which an equivalence 
determination could be based OR a statement that safety and 
effectiveness information about the [device name] will be made available 
to any interested person upon request. Safety and effectiveness 
information refers to adverse safety and effectiveness information, or 
descriptive information about the new and predicate devices, or 
performances/clinical testing information. 
If the summary option is selected, it should be included on a separate 
page and identified as the Summary of Safety and Effectiveness for 
[device name]. 
If the statement option is selected, do not include the word "summary" 
in the statement. 
The content and format of this information is specified in 57 FR No. 82, 
Tuesday, April 28, 1992, page 18062. 
J.  Contacts and Addresses 
General questions regarding the submission of premarket applications 
should be directed to the Division of Small Manufacturers Assistance at 
(800) 638-2041.  Questions  regarding this guidance document  should be directed to the 
following  address: 
FDA 
Division of  General  and Restorative Devices  (HFZ-410) 
Infection Control Devices Branch 
1390 Piccard Dr. 
Rockville,  MD.  20850 
(301)  594-1307  K.  Reviewer's Checklist 
510(k)  Number & 
Device Name 
Sponsor/Company 
Date :  Reviewer: 
ITEM  PRESENT  NEEDED 
Yes  No  (Y/N/?) 
I.  Cover Letter 
Proprietary name 
Common name 
Classification name 
Establishment Registration 
Procode(s) 
Purpose of submission 
Statement that the device 
is similar to and/or 
different from other product 
Contact person 
11.  Labels and Labeling 
Proposed labels &  labeling 
Labeling requirements 
Package labeling 
111.  Standards 
Standards listed 
IV .  Device Description 
Description of device 
Intended use(s)  Specifications 
V.  Descriptive Comparison to a Predicate 
- 
Labeling  -  - 
Intended use  - -  - 
Materials used  - -  - 
Performance  -  - 
VI.  Performance Data Supporting Substantial Equivalence 
Data provided  - -  - 
VII.  Sterility Information 
Sterile/non-sterile 
Sterilization method 
Validation method 
Sterility Assurance Level 
Packaging information 
EtO residues 
Radiation dose 
VIII. SMDA Requirements 
SlO(k) summary 
510(k)  statement  L.  COMPARISON TABLE 
Feature  New Device  Predicate 
Material Composition 
Weave 
Weight per yard square 
Thickness 
Strength 
Lint level 
BARRIER PERFORMANCE TESTS 
RESULTS : 
ASTM ES-21-1992 
ASTM ES-22-1992 
ASTM Dl424 
ASTM Dl682 
Flammability (NFPA 702) 
Sterilization Method 
Colorants 
Colorfastness 
Use Life  111.  Premarket Notifications for Kits 
In a 510(k)  submission for a kit, i.e., a package consisting of at least one 
medical device (such as surgical gowns or surgical drapes) and additional 
devices (such as surgeon's gloves), drugs, or biologics as other components, 
the applicant must provide the following: 
1.  Include a complete and specific listing of all components of the 
kit (s) . 
2.  Certifications: 
(a)  I certify that the medical device components of my kit 
listed on page(s)  [SUBMITTER PROVIDE PAGE NUMBERS] are 
either (1) legally marketed prearnendments devices, (2) 
exempt from premarket notification (consistent with the 
exemption criteria described in the classification 
regulations and the limitations of exemptions from Section 
510(k)  of the act (e.g., 21 CFR 862.9),  or (3) have been 
found to be substantially equivalent through the premarket 
notification process for the use(s)  for which the kit is 
intended (i.e., not claiming or causing a new use for the 
component(s)). 
(b)  I further certify that I purchase the device components in 
finished form, i.e., they are packaged, labeled, etc., 
consistent with their preamendments, exemption, or premarket 
notification criteria and status.  All purchased drug or 
biologic components are also packaged and labeled consistent 
with their approval or licensing. 
If you cannot make certification statement (a) for each device 
component of your kit, you must itemize the components without 
preamendments, exemption, or premarket notification status.  You 
must also supply adequate information so that FDA can evaluate the 
equivalence of these components of your kit.  This information may 
be the same information needed for a separate 510(k)  for each 
component. 
If you cannot make certification statement (b), then identify the 
components purchased in unfinished form, e.g., packaged in bulk 
(not final packaged and labeled in separate units). 
3.  Clearly identify in the list of kit components any that are drugs 
and biologics.  For example, state next to the item that it is a 
drug or a biologic. 
4.  Describe how the kit is assembled and processed into finished form 
for purchase (e.g., the components are taken out of the finished 
product or bulk packaging, component X is individually sterilized, 
all the components are then placed on a tray, the kit is wrapped, 
but not sterilized prior to shipment).  If there is any repackaging or reprocessing of a separate 
component, then you must provide details on the repackaging or 
processing and an analysis of the effect on the component.  This 
may require testing.  For example, for (re)sterilized devices 
conduct a validation study and provide data in accordance with the 
ODE Sterility Blue Book Memorandum.  The processing of the final 
kit is also important. You must evaluate whether the final 
processing for the kit as a whole affects the safety or 
effectiveness of any of the kit components. 
5.  The 510(k)  should include all labels and labeling for the kit.  A 
kit label alone may suffice for all components only if the label 
consolidates the required information typically found in labeling 
for each individual kit component when sold separately in final 
form. A  component may require specific labeling, such as a 
package insert, when adequate directions for use (precautions, 
warnings, etc.) are required.  It is important to examine the 
labeling for the individual components sold separately versus the 
labeling provided for the kit.  Verify that the labeling is 
adequate or enclose additional labeling in the kit, as needed. 
6.  Theitemsaboveidentifylabelingandprocessingissueswhichmay 
affect the regulatory status, or safety and effectiveness of the 
kit.  If you are aware of any other factor which may impact upon 
the status of your kit, then please bring it to our attention so 
that we may consider it in our evaluation.