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Premarket Notification

Requirements Concerning Gowns

Intended for Use in Health Care

Terrell Cunningham & Lauren Lilly

[Scientific Reviewers]

Infection Control Branch

Division of Anesthesiology, General Hospital, Infection 

Control and

Dental Devices

Center for Devices and Radiological Health, FDA

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Scope 

• Limited to gowns making liquid barrier protection 

claims and intended for use in health care settings. 

• Minimal or Low Barrier protection 

 ANSI/AAMI PB70 Level l protection or equivalent; or

 ANSI/AAMI PB70 Level2 protection or equivalent. 

• Moderate or High Barrier protection

 ANSI/AAMI PB70 Level 3 protection or equivalent; or

 ANSI/AAMI PB70 Level 4 protection or equivalent

 3 
Device Classification

• 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. 

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Class I Exempt Gown

NOT a "surgical gown" if all of the following factors 

apply:

• 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.

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Class II Gown

“Surgical Gown" if any of following applies:

• 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.

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Class II Gown 

Subject to Premarket Notification Submission 

[510(k)] 

• Surgical Gowns

• Surgical Isolation Gowns

– Isolation Gowns are Class I devices but become Class II 

devices if additional claims are made, such as moderate 

or high barrier function claims

– Isolation Gowns with such barrier function claims are 

defined as “surgical isolation gowns”

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FDA Premarket Review of 

Gowns

• 1993 guidance document for surgical gowns

• 2015 guidance document for surgical gowns

• Performance Testing

– Resist blood and liquid penetration - ANSI/AAMI PB70

• Safety Testing

– Biocompatibility

– Sterilization method and validation (surgical only) ( 

– Other properties: physical strength, comfort, heat dissipation, vapor 

transmission, linting, flammability, dyes

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FDA Premarket Review of 

Gowns

• Labeling 

– 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. 

– Identifies the level of liquid barrier protection per ANSI/AAMI PB70. 

– Direction(s) for use and indication(s) for use.

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Premarket Notification (510(k)) for 

Surgical Gowns and 

“Surgical Isolation Gowns" 

• Evidence that the gown complies with the claimed 

barrier performance criteria of ANSI/AAMI PB70, or 

equivalent standard.

• Performance test data to demonstrate that the gown 

is an effective barrier in accordance with ANSI/AAMI 

PB70.

• Clear description of the device design. 

• Identify all models, including dimensions, 

manufacturing specifications and tolerances, for each 

device design. 

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Premarket Notification (510(k)) for 

Surgical Gowns and 

“Surgical Isolation Gowns" 

• Representative engineering drawing(s), schematics, 

illustrations and/or figures of the gown labeled with 

the barrier protection levels, dimensions and the 

location of the critical and non-critical zones.

• Sample labeling that clearly identifies the level of 

liquid barrier protection per ANSI/AAMI PB70.

• Sample labeling that includes the direction(s) for use 

and indication(s) for use.

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Premarket Notification (510(k)) for 

Surgical Gowns and 

“Surgical Isolation Gowns" 

• List all components of the device and identify if each 

component is intended for single use only, single 

patient reusable, or multiple patient use. 

• Provide a comparison table of the device and the 

predicate device to support substantial equivalence. 

• Provide sterilization information as described in the 

guidance, Updated 510(k) Sterility Review Guidance 

K90-1 - Final Guidance for Industry and FDA. 

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Premarket Notification (510(k)) for 

Surgical Gowns and 

“Surgical Isolation Gowns" 

• 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). 

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Standards for Performance Testing of 

Surgical Gowns

Barrier Performance ANSI/AAMI PB70:2003

- 4 Levels of Performance at an AQL of 4%

 

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Level 1 AATCC 42:2000 </= 4.5gm

Level 2 AATCC 42:2000 

AATCC 127:1998 

</= 1.0gm

>/= 20cm

Level 3 AATCC 42:2000 

AATCC 

127:1998 

</= 1.0gm

>/=50cm

Level 4 ASTM F 

1671:2012 

PASS
- Non-Barrier Property Performance Testing

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Standards for Performance Testing of 

Surgical Gowns

Grab Tensile Strength ASTM D5034:1995

Snag Resistance ASTM D5587:1996 

ASTM D2582:2000

Linting IST 160.1:1995

Heat Loss ASTM F1868:1998 Part C

Water Vapor Transmission ASTM E96:20
- Non-Barrier Property Performance Testing cont. 

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Standards for Performance Testing of 

Surgical Gowns

Flammability 16 CFR Part 10(CPSC CS-191-53)

UL 2154

NFPA 702 1980 (Withdrawn)

Sterilization Sterilization Method and 

Validation

Reusable Laundering Instructions Recommended Number of Uses

Method for Tracking Number of 

Uses
- Performance Testing

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Standards for Performance Testing of 

Surgical Gowns

Biocompatibility Testing ISO 10993 Part 10

Skin Irritation

Skin Sensitization
Manufacturers proposing to market or those 

currently marketing Class II gowns as described in 

this guidance should:

• Submit a 510(k) for the gown to the Agency within 60 

days of publication of the final guidance

• Have a 510(k) submission for the gown accepted by 

the Agency for review within 75 days of publication 

of the final guidance 

• Obtain 510(k) clearance for the gown within 180 days 

of publication of the final guidance. 18

FDA Expectations for Manufacturers 
Relevant FDA Guidance 

Documents

• Premarket Notification Requirements Concerning 

Gowns Intended for Use in Health Care Settings

http://www.fda.gov/ucm/groups/fdagov-public/@fdagovmeddev-gen/documents/document/ucm452804.pdf

• Guidance on Premarket Notification [510(k)]

Submissions for Surgical Gowns and Surgical Drapes 

http://www.fda.gov/downloads/medicaldevices/deviceregulation

andguidance/guidancedocuments/ucm081305.pdf

 

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Relevant FDA Guidance 

Documents

• Updated 510(k) Sterility Review Guidance K90-1; Final Guidance 

for Industry and FDA 

http://www.fda.gov/RegulatoryInformation/Guidances/ucm0727

83.htm

• Guidance for Industry and FDA Staff: Format for Traditional and 

Abbreviated 510(k)s 

http://www.fda.gov/RegulatoryInformation/Guidances/ucm0843

65.htm

• The 510(k) Program: Evaluating Substantial Equivalence in 

Premarket Notifications [510(k)] Guidance for Industry and 

Food and Drug Administration Staff. 

http://www.fda.gov/downloads/MedicalDevices/.../UCM284443.

pdf 20
FDA Recognized Standards

• ASTM F2407

Standard Specification for Surgical Gowns Intended for Use in 

Healthcare Facilities

• ASTM F1670

Standard Test Method for Resistance of Materials Used in 

Protective Clothing to Penetration by Synthetic Blood

• AAMI/ANSI PB70

Liquid barrier performance and classification of protective apparel 

and drapes intended for use in health care facilities

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FDA Recognized Standards

• ASTM F1671

Standard Test Method for Resistance of Materials Used in 

Protective Clothing to Penetration by Blood-Borne Pathogens Using 

Phi-X174 Bacteriophage Penetration as a Test System

• AAMI ST65

Processing of reusable surgical textiles for use in health care 

facilities

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Questions? 

Division of Industry and Consumer Education: 

DICE@fda.hhs.gov

Slide Presentation, Transcript and Webinar 

Recording will be available at:

http://www.fda.gov/training/cdrhlearn

Under the heading-“Specialty Topics” (subsection- 

“Device-Specific Topics”)

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