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Enforcement Policy for Personal Protective 

Equipment (PPE) During COVID-19: Immediately 

in Effect Guidances

Office of Health Technology 4: Surgical and Infection Control Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

March 6, 2020
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• Introduction

• Devices

• Face Mask and Respirator Policies

• Emergency Use Authorizations (EUAs) for Face Masks, Surgical Masks, and N95 

Respirators 

• EUAs for Decontamination of Face Masks and Respirators

• Gowns

• Gloves

• Resources

• Questions

Agenda
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• To describe the FDA’s enforcement policies for face masks, respirators, gowns, 

and gloves.

• To describe the FDA’s Emergency Use Authorizations for non-NIOSH-approved 

disposable filtering facepiece respirators, NIOSH-approved air purifying 

respirators, and N95 respirator decontamination. 

Objectives
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• Most personal protective equipment, such as surgical gowns, face masks, and 

respirators are regulated by the FDA.

• The COVID-19 pandemic presents significant challenges to the availability of 

personal protective equipment in health care facilities.

• The FDA has authorized the emergency use of certain personal protective 

equipment and issued guidance on enforcement policies that together establish 

maximum regulatory flexibility to help facilitate access to critical medical 

supplies.

Background
Face Mask and Respirator Policies

Cynthia J. Chang, Ph.D.

Director 

Division of Infection Control & Plastic and 

Reconstructive Surgery Devices 
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Enforcement Policy for Face Masks and Respirators During the 

Coronavirus Disease (COVID-19) Public Health Emergency

• Achieve maximum regulatory flexibility while assuring products are appropriate 

for their use. 

• Discretion as to certain other FDA requirements

• In effect for the duration of the national emergency

Enforcement Policy Guidance
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• Face masks, face shields, and N95 respirators not intended for a medical 

purpose

• Face masks intended for a medical purpose that are not intended to provide 

liquid barrier protection

• Face shields intended for a medical purpose

• Surgical masks intended to provide liquid barrier protection

• Alternatives when FDA-cleared or NIOSH-approved N95 respirators are not 

available

Scope
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Face Mask 

A mask, with or without a face shield, that covers the 

user’s nose and mouth and may or may not meet fluid 

barrier or filtration efficiency levels.

N95 Respirator 

A disposable half-mask filtering facepiece respirator 

(FFR) that covers the user’s airway (nose and mouth) and 

offers protection from particulate materials at an N95 

filtration efficiency level per 42 CFR 84.181. An N95 FFR 

used in a health care setting is regulated by the FDA 

under 21 CFR 878.4040 (FDA product code MSH) and is 

either a class II device that is exempt from premarket 

notification or is a class II cleared device.
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Face Shield 

A face shield is a device used to protect the user's 

eyes and face from bodily fluids, liquid splashes, 

or potentially infectious materials. Generally, a 

face shield is situated at the crown of the head 

and is constructed with plastic to cover the user’s 

eyes and face.

Surgical mask 

A mask that covers the user’s nose and mouth and 

provides a physical barrier to fluids and particulate 

materials. The mask meets certain fluid barrier 

protection standards and Class I or Class II 

flammability tests, CPSC CS-191-53 Flammability 

Test Method (16 CFR 1610) Standard for 

Flammability of Clothing Textiles.
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The FDA does not intend to object to distribution and use (including 

importation) of the devices below without compliance with certain regulatory 

requirements, including 510(k), registration and listing, and quality system 

regulation requirements, when the devices are tested and labeled consistent 

with the enforcement policy.

Devices

• Face Shields Intended for a Medical Purpose

• Face Masks Intended for a Medical Purpose that are NOT Intended to 

Provide Liquid Barrier Protection

• Surgical Masks Intended to Provide Liquid Barrier Protection 

Enforcement Policy 
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When FDA-cleared or NIOSH-approved N95 respirators are not available, the 

FDA does not intend to object to the distribution (including importation) and use of 

respirators identified in the CDC recommendations: Strategies for Optimizing the 

Supply of N95 Respirators

Importers Note: For non-EUA products

• Because the FDA cannot confirm the authenticity of these respirators, the 

FDA recommends that importers take appropriate steps to verify the 

authenticity of the products they import. 

Alternatives When FDA-Cleared or NIOSH-Approved 

N95 Respirators are not Available
Emergency Use Authorizations (EUAs) for Face 

Masks, Surgical Masks, and N95 Respirators 

Cynthia J. Chang, Ph.D.

Director 

Division of Infection Control & Plastic and 

Reconstructive Surgery Devices 
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• Helps get promising medical products to patients as quickly as possible by 

allowing unapproved medical products or unapproved uses of approved medical 

products to be used in an emergency when there are no adequate, approved, 

and available alternatives

• Requires FDA review of performance, safety and labeling

• Allows devices not FDA-cleared or approved to be marketed in the U.S.

• Waives FDA cGMP and the quality system requirements, 21 CFR Part 820 

(design, manufacture, packaging, labeling, storage, and distribution)

• In effect for the duration of the national emergency

Emergency Use Authorization
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Detailed information on what to include in your EUA request is available 

in:

• NIOSH-Approved Air Purifying Respirators for Use in Health Care 

Settings During Response to the COVID-19 Public Health Emergency

• Non-NIOSH-Approved Disposable Filtering Facepiece Respirators 

Manufactured in China

• Imported, Non-NIOSH-Approved Disposable Filtering Facepiece 

Respirators

EUAs for Face Masks Intended for a Medical Purpose, 

Surgical Face Masks and N95 Respirators
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Requests should include: 

• General information

• Product labeling

• Whether the device currently has marketing authorization in another 

regulatory jurisdiction (including certification number)

• Whether the device is manufactured in compliance with 21 CFR Part 820, 

ISO 13485 or an equivalent quality system

• Description of testing conducted on the device

Send requests to CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov

EUA Requests
EUAs for Decontamination of Face Masks 

and Respirators 

Clarence Murray III, Ph.D.

Team Leader

Jon W. Weeks, Ph.D.

Scientific Reviewer
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Detailed information on what to include in your EUA request is 

available in Section VI. of the Enforcement Policy for Face Masks and 

Respirators During the Coronavirus Disease (COVID-19) Public Health 

Emergency

EUAs for Decontamination of Face Masks and 

Respirators 

Submit requests to: 

CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov
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Requests should include:

1. Critical Cycle Parameters

2. Validation of disinfection (bioburden reduction)

3. Chain of custody and safeguards to prevent inadvertent exposure

4. Material compatibility

5. Any applicable filtration performance

6. Fit test data

7. Labeling (decontaminated device)

EUAs for Decontamination of Face Masks and 

Respirators 
Gowns

BiFeng Qian, Ph.D.

Scientific Reviewer
21

Enforcement Policy for Gowns, Other Apparel, and Gloves During the 

Coronavirus Disease (COVID-19) Public Health Emergency

• Achieves maximum regulatory flexibility while assuring the product is 

appropriate for its use

• In effect for the duration of the national emergency

Enforcement Policy Guidance 
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• Gowns and other apparel are products intended to protect the user from the 

transfer of materials in the wearer’s environment. 

• The classification regulation and associated product codes for FDA-regulated 

gowns and other apparel covered by the guidance are listed in the resources 

section of this presentation

• FDA-regulated gowns and other apparel that are covered by the guidance are 

listed in the resources section of this presentation

• This guidance does not apply to Level 4 surgical gowns or togas. 

Scope
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Gowns

Minimal-to-Low Barrier Protection 

• ANSI/AAMI PB70 Level 1 protection or equivalent 

• ANSI/AAMI PB70 Level 2 protection or equivalent

Moderate-to-High Barrier Protection 

• ANSI/AAMI PB70 Level 3 protection or equivalent

• ANSI/AAMI PB70 Level 4 protection or equivalent
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The FDA does not intend to object to distribution and use (including 

importation) of the devices below without compliance with certain 

regulatory requirements, including 510(k), registration and listing, and 

quality system regulation requirements when the devices are tested and 

labeled consistent with the enforcement policy.

Devices

• Non-Surgical Gowns and Minimal-to-Low Barrier Protection Surgical 

Apparel

• Moderate-to-High Barrier Protection Surgical Gowns

Enforcement Policy
Gloves

BiFeng Qian, Ph.D.

Scientific Reviewer
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Patient Examination Glove

A disposable device intended for a medical purpose 

that is worn on the examiner’s hand or finger to 

prevent contamination between patient and 

examiner. 

Surgeon’s Glove 

A device intended to be worn on the hands of 

operating room personnel to protect a surgical 

wound from contamination.

Gloves
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Enforcement Policy for Gowns, Other Apparel, and Gloves During the 

Coronavirus Disease (COVID-19) Public Health Emergency

• Follow CDC’s recommendations on the use of PPE during the COVID-19 

outbreak

• Gloves not intended for medical purposes are not medical devices

• FDA-regulated gloves that are covered by the guidance are listed in the 

resources section of this presentation

• In effect for the duration of the national emergency

Enforcement Policy Guidance
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• When evaluating whether these products are intended for a medical 

purpose, among other considerations, the FDA will consider whether 

the product:

• Is labeled or otherwise intended for use by a health care professional;

• Is labeled or otherwise for use in a health care facility or environment; and

• Includes any drugs, biologics, or anti-microbial or anti-viral agent.

Gloves Not Intended for a Medical Purpose
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The FDA does not intend to object to distribution and use (including 

importation) of the devices below without compliance with certain regulatory 

requirements, including 510(k), registration and listing, and quality system 

regulation requirements when the devices are tested and labeled consistent 

with the enforcement policy.

Devices

• Patient Examination Gloves 

• Surgeon’s Gloves

Enforcement Policy 
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• Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease 

(COVID-19) Public Health Emergency

Comments may be submitted at any time for Agency consideration.

• Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID19) Public Health Emergency

Comments may be submitted at any time for Agency consideration.

• Battelle Decontamination System EUA

• NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to 

the COVID-19 Public Health Emergency

• Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators

Resources
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• EUA Clarification Letter on Respirators

• Non-NIOSH Approved Respirator EUA FAQ

• Fact Sheet for Healthcare Providers

• Instructions for Healthcare Facilities

• Instructions for Healthcare Personnel

• Strategies for Optimizing the Supply of N95 Respirators

• Surgical Mask and Gown Conservation Strategies - Letter to Healthcare 

Providers

• Medical Glove Conservation Strategies: Letter to Health Care Providers

Resources
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Gown Regulations and Product Codes

Classification Regulation Device Type Product Code Class

21 CFR 878.4040 Conductive Shoe and Shoe Cover BWP I (exempt)

21 CFR 878.4040 Operating-Room Shoes FXW I (exempt)

21 CFR 878.4040 Surgical Apparel Accessory LYU I (exempt)

21 CFR 878.4040 Non-surgical isolation gowns OEA I (exempt)

21 CFR 878.4040 Surgical suits FXO I (exempt)

21 CFR 878.4040 Operating-room shoe covers FXP I (exempt)

21 CFR 878.4040 Surgical helmets FXZ I (exempt)

21 CFR 878.4040 Surgical dress FYE I (exempt)

21 CFR 878.4040 Surgical caps FYF I (exempt)

21 CFR 878.4040 Surgical gown/toga FYA II

21 CFR 878.4040 Patient gown FYB II

21 CFR 878.4040 Surgical isolation gown FYC II

21 CFR 878.4040 Surgical hood FXY II
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Glove Regulation and Product Codes

Classification Regulation Device Type Product Code Class

21 CFR 880.6250 Patient examination glove FMC I (reserved)

21 CFR 880.6250 Latex Patient Examination Glove LYY I (reserved)

21 CFR 880.6250 Polymer Patient Examination Glove LZA I (reserved)

21 CFR 880.6250 Finger Cot LZB I (exempt)

21 CFR 880.6250 Vinyl Patient Examination Glove LYZ I (reserved)

21 CFR 880.6250 Powder-Free Guayle Rubber Examination 

Glove

OIG I (reserved)

21 CFR 880.6250 Powder-Free Polychloroprene Patient 

Examination Glove

OPC I (reserved)

21 CFR 880.6250 Radiation Attenuating Medical Glove OPH I (reserved)

21 CFR 880.6250 Specialty Patient Examination Glove LZC I (reserved)

21 CFR 878.4460 Surgeon’s Gloves KGO I (reserved)

21 CFR 878.4460 Powder-Free Non-Natural Rubber Latex 

Surgeon’s Gloves

OPA I (reserved)
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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 Heading: Special Technical Topics; Subheading: Device 

Specific Topics