Contains Nonbinding Recommendations 
 
 
Premarket Notification 
Requirements Concerning Gowns 
Intended for Use in Health Care 
Settings  
Guidance for Industry and  
Food and Drug Administration Staff 
 
Document issued on December 9, 2015.  
The draft of this document was issued on June 30, 2015. 
 
 
For questions about this document, contact the Division of Anesthesiology, General Hospital, 
Respiratory, Infection Control, and Dental Devices, 301-796-5580, and Elizabeth Claverie, 
301-796-6298, Elizabeth.claverie@fda.hhs.gov.  
 
 
 
 
 
 
 
 
 
 
 
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, Respiratory,  
Infection Control and Dental Devices 
  1  Contains Nonbinding Recommendations 
 
 
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 FDA-2015-D-2261. 
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 1500025 to identify the guidance you are requesting. 
  2  Contains Nonbinding Recommendations 
 
 
Premarket Notification 
Requirements Concerning Gowns 
Intended for Use in Health Care 
Settings  
 
Guidance for Industry and  
Food and Drug Administration Staff  
 
This guidance represents the current thinking of the Food and Drug Administration (FDA 
or Agency) on this topic.  It does not establish any rights for any person and is not binding 
on FDA or the public.  You can use an alternative approach if it satisfies the requirements 
of the applicable statutes and regulations.  To discuss an alternative approach, contact the 
FDA staff or Office responsible for implementing this guidance as listed on the title page. 
I.  Introduction 
The Food and Drug Administration (FDA) is issuing this guidance to describe the Agencys 
premarket regulatory requirements and the performance testing needed to support liquid 
barrier claims for gowns intended for use in health care settings.  This guidance is being 
issued in light of the public health importance of personal protective equipment in health care 
settings and the recognition that terminology used to describe gowns has evolved, including 
by FDA, industry, the standards community, and health care professionals.   
 
FDA believes this guidance is important to promote and protect public health by describing 
premarket regulatory requirements pertaining to gowns regulated under 21 CFR 878.4040. 
Specifically, it will describe for industry the premarket regulatory requirements and data 
requirements for marketing of gowns with claims that they meet certain liquid barrier 
performance standards established by the American National Standards Institute, Inc., and 
the Association for the Advancement of Medical Instrumentation (ANSI/AAMI) and other 
similar terminology associated with these claims. 
FDA recognizes that differences in terminology used to describe the functional performance 
of various kinds of gowns intended to provide liquid barrier protection in health care settings 
have developed among FDA, industry, the standards community, and health care 
professionals.  While this guidance document will not resolve existing differences in 
  3  Contains Nonbinding Recommendations 
 
 
terminology, it is intended to clarify FDAs premarket notification requirements for gowns 
making liquid barrier protection claims intended for use in health care settings.  
This document is intended to supplement the 1993 guidance document, Guidance on 
Premarket Notification [510(K)] Submissions for Surgical Gowns and Surgical Drapes 
(http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocu
ments/ucm081305.pdf). 
For the current edition of the FDA-recognized standard(s) referenced in this document, see 
the FDA Recognized Consensus Standards Database Web site at 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agencys 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 guidance means that 
something is suggested or recommended, but not required.   
II.  Background 
FDA issued a final rule1 on June 24, 1988, defining surgical apparel under 21 CFR 
878.4040 as: 
devices that are intended to be worn by operating room personnel during surgical 
procedures to protect both the surgical patient and the operating room personnel 
from  transfer  of  microorganisms,  bodily  fluids,  and  particulate  material.  
Examples include surgical caps, hoods, masks, gowns, operating room shoes and 
shoe  covers,  and  isolation  masks  and  gowns.    Surgical  suits  and  dresses, 
commonly known as scrub suits, are excluded. 
Under this 1988 final rule, surgical gowns and surgical masks were classified as Class II 
subject to premarket review under section 510(k) of the Federal Food, Drug, and Cosmetic 
Act, and surgical apparel other than surgical gowns and surgical masks, were classified as 
Class I also subject to 510(k) premarket review requirements.  A manufacturer of any gown 
that met the intended use of surgical apparel under 21 CFR 878.4040 was required to submit 
a 510(k) notification before the device could be introduced into interstate commerce. 
 
On January 14, 2000, FDA issued a final rule2 to designate as exempt from premarket 
notification (510(k)) requirements surgical apparel other than surgical gowns and surgical 
masks, subject to the limitations of exemptions under 21 CFR 878.9, which includes 
requiring a premarket notification for devices intended for a use different from the intended 
use of a legally marketed device in that generic type of device.  Specifically, the 
classification regulation was modified to read: 
                                                           
1 53 FR 23874 (June 24, 1988). 
2 65 FR 2318(January 14, 2000). 
  4  Contains Nonbinding Recommendations 
 
 
21 CFR 878.4040 Surgical apparel.  
(a) Identification. Surgical apparel are devices that are intended to be 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. Examples include surgical caps, hoods, masks, 
gowns, operating room shoes and shoe covers, and isolation masks and gowns. 
Surgical suits and dresses, commonly known as scrub suits, are excluded.  
(b) Classification. (1) Class II (special controls) for surgical gowns and surgical 
masks. 
(2) Class I (general controls) for surgical apparel other than surgical gowns and 
surgical masks. The class I device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to  878.9. 
At the time of the 2000 final rule, the Agency viewed surgical gowns as gowns intended 
for use during surgical procedures and/or for use to provide moderate to high level barrier 
protection and isolation gowns as gowns intended to provide minimal or low levels of 
barrier protection.  For the purposes of this guidance, isolation gowns that are intended for 
use to provide moderate to high level barrier protection are referred to as surgical isolation 
gowns.   
Since the original 1988 final rule, a number of terms have been used to refer to gowns 
intended for use in health care settings including, but not limited to, surgical gowns, isolation 
gowns, surgical isolation gowns, nonsurgical gowns, cover gowns, comfort gowns, 
procedural gowns, and operating room gowns. Although the Agency has not defined the 
other terms by regulation or guidance, in its 1993 guidance, the Agency referred to the 
regulation definition of the term surgical gowns which was 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.3  In addition, the Agency has reviewed certain gowns based on the intended use of 
those gowns as surgical gowns and was able to determine substantial equivalence to the other 
surgical gowns classified under 21 CFR 878.4040(b)(1), based on assessments of liquid 
chemical permeation, fluid penetration, viral penetration and other appropriate scientific 
analysis.     
In 2004, FDA recognized the consensus standard ANSI/AAMI PB70:2003, Liquid barrier 
performance and classification of protective apparel and drapes intended for use in health 
care facilities.4  ANSI/AAMI PB70 utilized new terminology for barrier performance of 
gowns. This terminology described and assessed the barrier protection levels of gowns and 
                                                           
3 Guidance on Premarket Notification [510(k)] Submission for Surgical Gowns and Surgical Drapes, August 
1993.(http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm08
1305.pdf) 
4 Approved on October 23, 2003 by American National Standards Institute, Inc. 
  5  Contains Nonbinding Recommendations 
 
 
other protective apparel intended for use in health care facilities, by specifying test methods 
and performance results necessary to verify and validate the newly defined levels of barrier 
protection.  Although FDA has recognized ANSI/AAMI PB70s barrier performance levels 
(i.e., Levels 1-4) and the associated test methods, the definitions and terminology used in this 
standard are inconsistent with FDAs historical definitions of these terms.  Thus, the 
differences in regulatory and standards terminology have added confusion in the market-
place as it relates to regulatory requirements for gowns with liquid barrier protection claims.  
Specifically, ANSI/AAMI PB70 defines an isolation gown as an [i]tem of protective 
apparel used to protect health care personnel and patients from the transfer of 
microorganisms and body fluids in patient isolation situations, and surgical gowns as 
devices that are intended to be worn by operating room personnel during surgical 
procedures to protect both the surgical patient and the operating room personnel from the 
transfer of microorganisms, body fluids, and particulate matter [material].5    Under 21 
CFR 878.4040 and the Agencys regulatory approach, however, both surgical gowns and 
isolation gowns are surgical apparel, and surgical isolation gowns are considered to be 
class II surgical gowns because they are intended for use as such based on their moderate 
to high barrier protection claims.     
The Agency has considered gowns that claim moderate to high barrier protection, such as 
ANSI/AAMI PB70 Level 3 or 4, to be a higher risk device than those that claim minimal or 
low levels of barrier protection, such as ANSI/AAMI PB70 Level 1 or 2.  Thus, FDA 
considers both level-of-protection claims and the terminology used (e.g., isolation, 
nonsurgical, procedural, operating room) because of such devices substantial importance in 
preventing impairment of human health.  The level of protection claimed is particularly 
relevant in light of the inconsistent terminology used, and that, at the time of the 2000 final 
rule, surgical apparel other than surgical gowns and surgical masks were associated with low 
levels of barrier protection.  The purpose of this guidance, therefore, is to clarify and describe 
the premarket regulatory requirements pertaining to gowns regulated under 21 CFR 878.4040 
and the performance testing needed to support liquid barrier claims for gowns intended for 
use in health care settings. 
III.  Scope 
The scope of this document is limited to gowns making liquid barrier protection claims and 
intended for use in health care settings.  For the purposes of this guidance document: 
Minimal or Low Barrier protection6 refers to: 
  ANSI/AAMI PB70 Level 1 protection or equivalent; or  
  ANSI/AAMI PB70 Level 2 protection or equivalent.  
                                                           
5 See, respectively, sections 3.13 and 3.31 of the ANSI/AAMI PB 70:2012 (citing 21 CFR 878.4040).   
6 Prior to the existence of ANSI/AAMI PB70, minimal or low barrier protection claims included, but were not 
limited to, Protective Apparel,  Effective Barrier, Fluid-Resistant, Water  Resistant, and Splash 
Resistant.  The Agency discourages the use of these claims because they lack specificity with respect to 
performance characteristics and test methods.  ANSI/AAMI PB70 was developed to address these issues and 
provide clarity to the user community regarding the levels of liquid barrier protection provided by a gown.  
  6  Contains Nonbinding Recommendations 
 
 
Moderate or High Barrier protection7 refers to: 
  ANSI/AAMI PB70 Level 3 protection or equivalent; or  
  ANSI/AAMI PB70 Level 4 protection or equivalent  
 
This guidance document does not address the data needed to support gowns making claims 
of providing protection against specific organisms, chemical agents, chemotherapy drugs or 
those making specific disease prevention claims (such as protects against Ebola).  In 
addition, this guidance does not address the data needed to support the addition of 
antimicrobial agents in gowns.  Manufacturers desiring to market gowns with these types of 
claims and/or design features are encouraged to utilize the pre-submission process8 to obtain 
 
further guidance from the Agency prior to the submission of a premarket submission.
IV.  Policy 
The Agency is describing its approach to determining which gowns are Class I and which are 
Class II.  Specifically, consistent with 21 CFR 878.4040(b), a gown that is not intended for 
use as a surgical gown is a Class I exempt device that is not subject to premarket notification 
requirements, and a gown that is intended for use as a surgical gown is a class II device 
subject to premarket notification.  The determination of the intended use of a device is 
factually driven and generally made on a case-by-case basis.  In determining whether a gown 
is intended for use as a surgical gown under 21 CFR 878.4040(b)(1) that is class II subject 
to premarket notification, the Agency considers a number of factors, including, but not 
limited to, the terminology used, level of barrier protection claimed, and the devices 
technological characteristics.   
a)  Class I exempt gowns 
 
For purposes of determining classification of a gown under 21 CFR 878.4040(b), the 
Agencys regulatory approach is that a gown falling within this regulation is not a surgical 
gown if all of the following factors exist: 
  it is labeled as a gown other than a surgical gown (e.g., isolation gown);  
  it is not described in its labeling as a surgical gown; and 
  if it has statements relating to barrier protection, such statements are for only minimal 
or low barrier protection.   
                                                           
7 Prior to the existence of ANSI/AAMI PB70, moderate or high barrier protection claims included, but were not 
limited to, Prevents Strikethrough,  Highest Fluid Protection, Impervious, Highest Level of Protection, 
and Impermeable.  The Agency discourages the use of these claims because they lack specificity with respect 
to performance characteristics and test methods.  ANSI/AAMI PB70 was developed to address these issues and 
provide clarity to the user community regarding the levels of liquid barrier protection provided by a gown. 
8 Please see FDA guidance document, Requests for Feedback on Medical Device Submissions: The Pre-
Submission Program and Meetings with Food and Drug Administration Staff: Guidance for Industry and Food 
and Drug Administration Staff. 
(http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.
pdf) 
  7  Contains Nonbinding Recommendations 
 
 
In that case, the labeling or descriptions of the device, along with any minimal or low barrier 
protection (or no barrier protection) claims, show that its intended use is as a nonsurgical 
gown.  Such a gown is considered class I, exempt from premarket notification under 21 CFR 
878.4040(b)(2), subject to the limitations in 21 CFR 878.9, as surgical apparel other than 
surgical gowns and surgical masks.  The device is class I exempt because the general 
controls are sufficient to provide reasonable assurance of the safety and effectiveness of the 
device, under section 513(a)(1)(A) of the FD&C Act.  The general controls include, but are 
not limited to, the quality system regulation (21 CFR part 820), registration and listing (21 
CFR part 807), medical device reporting (21 CFR part 803), and labeling (21 CFR part 801). 
b)  Class II gowns 
 
For purposes of determining classification of a gown under 21 CFR 878.4040(b), the 
Agencys regulatory approach is that a gown falling within this regulation is a surgical 
gown if: 
  it is labeled as such;  
  it is described as such in its labeling;  
  it has statements relating to moderate or high level barrier protection; and/or 
  it has statements that it is intended for use during sterile procedures.   
In that case, the terminology (e.g., surgical gown or surgical isolation gown); description 
in the gowns labeling (e.g., this gown is suitable as a surgical gown); and/or Level 3 or 4 
barrier protection claims show that the gown is intended for use as a surgical gown (which 
includes surgical isolation gown).  Such gowns are considered class II devices under 21 
CFR 878.4040(b)(1) and are subject to premarket notification.  The Agency considers gowns 
that claim moderate to high level barrier protection, such as ANSI/AAMI PB70 Level 3 or 4, 
to be a higher risk device than those that claim minimal or low levels of barrier protection, 
such as ANSI/AAMI PB70 Level 1 or 2, because of such devices substantial importance in 
preventing impairment of human health, and, thus, the Agency considers such gowns to be 
surgical gowns within the meaning of 21 CFR 878.4040(b)(1).  
 
Statements in the labeling that a gown is a surgical gown (which includes surgical isolation 
gown) provide strong evidence that the gown is a surgical gown, as that term is used in 21 
CFR 878.4040(b)(1), even if there are claims that the gown only provides minimal or low 
barrier protection.   
 
When a premarket notification (510(k)) for a surgical gown (which includes surgical 
isolation gown) falling within this section is submitted for FDA review, the 510(k) should 
contain the following information in addition to the items identified in FDAs Guidance on 
Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes 
(http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocu
ments/ucm081305.pdf ): 
1.  Evidence that the gown complies with the claimed barrier performance criteria of the 
currently FDA-recognized version of ANSI/AAMI PB70, or equivalent standard.  
  8  Contains Nonbinding Recommendations 
 
 
ANSI/AAMI PB70 establishes barrier performance and documentation requirements 
for gowns and their materials.   
2.  Performance test data to demonstrate that the gown is an effective barrier in 
accordance with ANSI/AAMI PB70 barrier performance specifications. For both 
single use and reusable gowns, barrier performance testing should be completed on 
the final, finished, pre-shipment gown, at the end of the stated shelf life of the gown.  
If the gown is intended to be reusable, barrier performance testing should also be 
performed at the end of the labeled use-life (maximum reprocessing cycles).    
3.  Representative engineering drawing(s), schematics, illustrations and/or figures of the 
gown that are clear, legible, labeled with the barrier protection levels of the gown, 
and include dimensions and the location of the critical and non-critical zones. 
4.  Sample labeling that clearly identifies the level of liquid barrier protection per 
ANSI/AAMI PB70. 
 
5.  Sample labeling that includes the direction(s) for use and indication(s) for use. 
Current Agency policy is to require the submission of a premarket notification (510(k)) for 
manufacturers proposing to begin the introduction or delivery for introduction into interstate 
commerce for commercial distribution a gown falling within section IV.b.  The Agency does 
not intend to enforce compliance with premarket notification requirements for gowns 
marketed on or before June 26, 2015 that fall within section IV.b. and do not have an existing 
510(k) clearance when manufacturers: 1) submit a 510(k) for the gown to the Agency within 
60 days of publication of the final guidance; 2) have a 510(k) submission for the gown 
accepted by the Agency for review within 75 days of publication of the final guidance;9 and 
3) obtain 510(k) clearance for the gown within 180 days of publication of the final guidance.  
Manufacturers can bundle multiple gowns within a single 510(k) submission.10 FDA intends 
to work interactively with manufacturers, as appropriate, during the review process.  If a 
manufacturer has complied with steps 1 and 2 above, but has not received clearance for its 
device within 180 days because the submission remains under active review, the 
manufacturer should contact FDA to discuss whether the Agency intends to continue to defer 
enforcement under these circumstances.    
                                                           
9 Please see FDA guidance document, Refuse to Accept Policy for 510(k)s. 
(http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm315014.
pdf)  In order to be considered administratively complete and accepted for review, submissions should contain 
the items identified in Section IV.b. 
10 Please see FDA guidance document, Bundling Multiple Device or Multiple Indications in a Single 
Submission. (http://www.fda.gov/RegulatoryInformation/Guidances/ucm089731.htm) 
  9