March 6, 2023 

To: Manufacturers of Surgical Masks; 

Health Care Personnel; 

Hospital Purchasing Departments; 

Authorized Distributors and Authorized Importers; and

Any Other Stakeholders 

On February 4, 2020, pursuant to section 564(b)(1)(C) of the Federal, Food, Drug, and Cosmetic 

Act (the Act) (21 U.S.C. §360bbb-3(b)(1)(C)), the Secretary of the Department of Health and 

Human Services (HHS) determined that there is a public health emergency that has a significant 

potential to affect national security or the health and security of United States citizens living 

abroad, and that involves the virus that causes Coronavirus Disease 2019 (COVID-19).1

 

Pursuant to section 564 of the Act, and on the basis of such determination, the Secretary of HHS 

then declared on March 24, 2020, that circumstances exist justifying the authorization of 

emergency use of medical devices, including alternative products used as medical devices, due to 

shortages during the COVID-19 pandemic, subject to the terms of any authorization issued under 

that section.2 

On August 5, 2020, the U.S. Food and Drug Administration (FDA) granted Emergency Use 

Authorization (EUA) for disposable, single-use surgical masks3, 4 (hereafter also referred to as 

“surgical masks”) for use in healthcare settings by healthcare personnel (HCP)5 as personal 

1 U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration 

that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and 

Cosmetic Act, 21 U.S.C. § 360bbb-3. 85 FR 7316 (February 7, 2020). 2 U.S. Department of Health and Human Services, Declaration that Circumstances Exist Justifying Authorizations 

Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3, 85 FR 17335

(March 27, 2020). 3

 A surgical mask is a mask that covers the user’s nose and mouth and provides a physical barrier to fluids and 

particulate materials. Surgical masks are generally regulated by FDA as Class II devices under 21 CFR 878.4040 – 

Surgical apparel.

4 FDA-cleared surgical face masks, non-surgical face masks, surgical masks with antimicrobial/antiviral agent, and 

all particulate filtering facepiece respirators are not within the scope of this authorization. 5 For the purposes of this EUA, HCP refers to all paid and unpaid persons serving in healthcare settings who have 

the potential for direct or indirect exposure to patients or infectious materials, including body substances (e.g., 

blood, tissue, and specific body fluids); contaminated medical supplies, devices, and equipment; contaminated 

environmental surfaces; or contaminated air. These HCP include, but are not limited to, emergency medical service 

personnel, nurses, nursing assistants, physicians, technicians, therapists, phlebotomists, pharmacists, dentists and 

dental hygienists, students and trainees, contractual staff not employed by the healthcare facility, and persons not 

directly involved in patient care, but who could be exposed to infectious agents that can be transmitted in the 

healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities 

management, administrative, billing, and volunteer personnel).
Page 2 

protective equipment (PPE)6 to provide a physical barrier to fluids and particulate materials to 

prevent HCP exposure to respiratory droplets and large particles during surgical mask 

shortages resulting from the COVID-19 pandemic, pursuant to section 564 of the Act (21 

U.S.C. 360bbb-3).

Since August 5, 2020, FDA has continued to periodically review the circumstances and the 

appropriateness of authorizing the emergency use of surgical masks under this EUA as 

required by section 564(g)(1) of the Act. FDA has now determined that revision and 

reissuance of this EUA is appropriate, based on the totality of scientific evidence available, 

which includes information regarding supply, demand and distribution, and information

compiled from requests for addition of surgical masks to Appendix A7 of the EUA, premarket 

submissions, and imports data. Based on this review and all available information, FDA has 

concluded that the criteria for issuance under section 564(c) of the Act are met with respect to 

the surgical masks listed in Appendix A as of the date of this reissuance. In doing so, FDA has 

determined that it is appropriate to revise the scope of this authorization. As such, pursuant to 

section 564(g)(2)(C) of the Act, and as outlined in Section II of this letter, the scope is being 

revised such that no additional surgical masks will be added to Appendix A. 

Having concluded that revising the August 5, 2020 letter is appropriate to protect the public 

health or safety under section 564(g)(2)(C) of the Act (21 U.S.C. § 360bbb-3(g)(2)(c)), FDA is 

reissuing the August 5, 2020 letter in its entirety8 with the revisions9 incorporated to authorize 

the emergency use of authorized surgical masks in Appendix A. No additional surgical masks

will be added to Appendix A as a result of this revision. 

Having concluded that the criteria for issuance of this authorization under section 564(c) of the 

Act are met, I am authorizing the emergency use of the authorized surgical masks that are in 

Appendix A as set forth in Section II pursuant to the Conditions of Authorization (Section IV) of 

this letter. 

I. Criteria for Issuance of Authorization

I have concluded that the emergency use of authorized surgical masks listed in Appendix A meet 

the criteria for issuance of an authorization under section 564(c) of the Act, because I have 

concluded that: 

6 Surgical masks may be effective in blocking splashes and large particle droplets. While surgical masks are not 

protective against smaller airborne particulates as described in Section II, they are considered PPE because they are 

intended to be used to protect HCP from infectious disease hazards. Surgical masks are different from non-surgical 

face masks, which are only used as source control by the general public and are not considered PPE. 7 Appendix A: Authorized Surgical Masks is available at https://www.fda.gov/medical-devices/coronavirusdisease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipmenteuas#appendixasurgicalmasks. 8 This letter, which was originally issued on August 5, 2020, is being reissued in its entirety. 9 The March 6, 2023, revisions to the August 5, 2020, letter removes the eligibility criteria so that no additional 

surgical masks will be added to Appendix A. 
Page 3 

1. SARS-CoV-2, the virus that causes COVID-19, can cause a serious or life-threatening 

disease or condition, including severe respiratory illness, to humans infected by this 

virus; 

2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe 

that the authorized surgical masks listed in Appendix A may be effective for use in 

healthcare settings by HCPs as PPE to provide a physical barrier to fluids and particulate 

materials to prevent HCP exposure to respiratory droplets and large particles during 

surgical mask shortages resulting from the COVID-19 pandemic, and that the known and 

potential benefits of the authorized surgical masks, when used consistent with the scope 

of this authorization (Section II), outweigh the known and potential risks of such 

products; and

3. There is no adequate, approved, and available alternative to the emergency use of these 

authorized surgical masks for use in healthcare settings by HCP to prevent HCP exposure 

to respiratory droplets and large particles during surgical mask shortages resulting from 

the COVID-19 pandemic.10,11

II. Scope of Authorization

I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is 

limited to the use of the authorized surgical masks listed in Appendix A, for use in healthcare 

settings by HCP as PPE to provide a physical barrier to fluids and particulate materials to prevent

HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting 

from the COVID-19 pandemic. 

Surgical masks are not intended to replace the need for FDA-cleared surgical masks or FDAcleared or authorized respirators. Surgical masks may be effective in blocking splashes and 

large-particle droplets; however, because of the loose fit between the surface of the surgical 

mask and the user’s face, leakage can occur around the edge of the mask when the user inhales. 

Therefore, a surgical mask may not provide the user with a reliable level of protection from 

inhaling smaller airborne particles and is not considered respiratory protection. For this reason, 

surgical masks are not recommended for use in aerosol generating procedures and any clinical 

conditions where there is significant risk of infection through inhalation exposure. In such 

clinical conditions, a filtering facepiece respirator (such as an N95 respirator) with a tight fit is 

recommended to provide a more reliable level of respiratory protection against pathogenic 

biologic airborne particulates. 

10 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act. 11 Though supply and demand are stabilizing and there is an increased number of FDA-cleared alternatives 

available, there are not sufficient quantities of 510(k) cleared surgical masks to meet the needs of the U.S. healthcare 

system. These articles of PPE are an integral part of patient care during the COVID-19 pandemic. Providing 

continued authorization for the surgical masks listed in Appendix A helps meet the needs of the healthcare system. 

Providing HCP who are on the forefront of the COVID-19 response with sufficient PPE is necessary in order to 

reduce the risk of illness in HCP and increase their availability to provide care to affected patients or those suspected 

of having COVID-19.
Page 4 

The Authorized Surgical Masks 

Surgical masks authorized by this EUA12 for the above-described intended use are currently 

listed in Appendix A. All authorized surgical masks listed in Appendix A were listed in 

Appendix A at the time of this reissuance and meet the following performance criteria:

• Fluid resistance requirements (liquid barrier performance) consistent with ASTM 

F1862: Standard Test Method for Resistance of Medical Face Masks to 

Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a 

Known Velocity); 13 

• Flammability performance consistent with the definition of either a Class 1 or 

Class 2 textile in 16 CFR Part 1610; 

• Particulate filtration efficiency requirements consistent with ASTM F2100: Standard 

Specification for Performance of Materials Used in Medical Face Masks; 

• Air flow resistance (i.e., breathability) requirements with an acceptance criterion of 

<6 mm H2O/cm2 for differential pressure (delta P) testing consistent with ASTM 

F2100: Standard Specification for Performance of Materials Used in Medical Face 

Masks for those masks composed of 4 or more layers; and 

• The materials of manufacture are either (1) non-cytotoxic, non-irritating and nonsensitizing consistent with the recommendations in FDA’s guidance, “Use of 

International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 

1: Evaluation and testing within a risk management process’”14 or (2) conform to the 

following biocompatibility standards: 

• ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation 

and testing within a risk management process 

• ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in 

vitro cytotoxicity 

• ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for 

irritation and skin sensitization.

The labeling of the authorized surgical masks must: 

• Describe the product as a disposable, single-use surgical mask. The labeling must 

include a list of the body contacting materials (which does not include any drugs, 

biologics, nanoparticles, or antimicrobial/antiviral agents); 

12 Surgical masks that were: (1) FDA-cleared; (2) manufactured in China; or (3) included drugs, biological, 

nanoparticles or antimicrobial/antiviral agents were excluded from the scope of the August 5, 2020 letter, and were 

not authorized under this EUA.

13 For the current edition of the FDA-recognized consensus standards referenced in this document, see the FDA 

Recognized Consensus Standards Database, available at

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. For more information regarding use of 

consensus standards in regulatory submissions, refer to the FDA guidance titled “Appropriate Use of Voluntary 

Consensus Standards in Premarket Submissions for Medical Devices,” available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarketsubmissions-medical-devices. 14 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso10993-1-biological-evaluation-medical-devices-part-1-evaluation-and. 
Page 5 

• State that the product is not intended to replace the need for FDA-cleared surgical 

masks or FDA-cleared or authorized respirators; 

• State that surgical masks are not intended to provide protection against pathogenic 

biological airborne particulates and are not recommended for use in aerosol 

generating procedures and any clinical conditions where there is significant risk of 

infection through inhalation exposure; and

• Not include statements that would misrepresent the product or create an undue risk in 

light of the public health emergency. For example, the labeling must not include any 

express or implied claims for: (1) reuse, (2) antimicrobial or antiviral protection or 

related uses, (3) infection prevention, infection reduction, or related uses, or (4) viral 

filtration efficiency. 

Authorized products must be accompanied by the above required labeling, and in addition, the 

authorized products must be accompanied by the following information pertaining to the 

emergency use, which are authorized to be made available to HCPs: 

• Fact Sheet for Healthcare Personnel: Emergency Use of Authorized Disposable, SingleUse Surgical Masks During the COVID-19 Pandemic

The manufacturer’s labeling (which must meet the labeling requirements specified above) and 

the fact sheet, are referred to as “authorized labeling.” 

Authorized products are subject to surveillance and monitoring. FDA may remove an authorized 

surgical mask from Appendix A of this EUA if FDA has reason to believe that the product no 

longer meets the Scope of Authorization (Section II). FDA will provide the manufacturer 24 

hours advance notice of such removal. Products that are removed from Appendix A will be 

included on a list maintained on FDA’s EUA webpage. 

The above-described authorized surgical masks listed in Appendix A are authorized to be 

distributed to and used in healthcare settings by HCP as PPE to provide a physical barrier to 

fluids and particulate materials to prevent HCP exposure to respiratory droplets and large 

particles during surgical mask shortages resulting from the COVID-19 pandemic. 

I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the 

known and potential benefits of authorized surgical masks as described within this section (the 

Scope of Authorization, Section II), outweigh the known and potential risks of such products. 

I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific 

evidence available to FDA, that it is reasonable to believe that authorized surgical masks may be 

effective as described within this section (the Scope of Authorization, Section II), pursuant to 

section 564(c)(2)(A) of the Act. 
Page 6 

FDA has reviewed the scientific information available to FDA, including the information 

supporting the conclusions described in Section I above, and concludes that authorized surgical 

masks (as described in the Scope of Authorization, Section II), meet the criteria set forth in 

section 564(c) of the Act concerning safety and potential effectiveness.

The emergency use of authorized surgical masks must be consistent with, and may not exceed, 

the terms of this letter, including the Scope of Authorization (Section II) and the Conditions of 

Authorization (Section IV). Subject to the terms of this EUA and under the circumstances set 

forth in the Secretary of HHS’s determination under section 564(b)(1)(C) described above and 

the Secretary of HHS’s corresponding declaration under section 564(b)(1), surgical masks that 

are determined to meet the criteria set forth in this section (Section II) are authorized under the 

terms and conditions of this EUA. 

III. Waiver of Certain FDA Requirements

 

I am waiving applicable current good manufacturing practice requirements, including the quality 

system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, 

labeling, storage, and distribution of the authorized surgical masks that are used in accordance 

with this EUA.

IV. Conditions of Authorization 

Pursuant to section 564(e) of the Act, I am establishing the following conditions to this 

authorization: 

Manufacturers of Authorized Products

A. Manufacturers must make authorized products available with the authorized labeling 

(including the labeling requirements described in Section II). Manufacturers must 

make available all labeling in English, to each end user facility (e.g., each hospital) 

that receives the authorized products, and may include the authorized labeling with 

each individual authorized product. 

B. Manufacturers must comply with 21 CFR Part 803, and must have a process in place 

for reporting adverse events of which they become aware to FDA consistent with 21 

CFR Part 803. See FDA’s webpage “Medical Device Reporting (MDR): How to 

Report Medical Device Problems”15 for additional information concerning reporting 

requirements under 21 CFR Part 803 and procedures.

C. Manufacturers must ensure that any records associated with this EUA are maintained 

until otherwise notified by FDA. Such records must be made available to FDA for 

inspection upon request. 

 

15 FDA’s webpage titled “Medical Device Reporting (MDR): How to Report Medical Device Problems” is available 

at https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medicaldevice-problems. 
Page 7 

D. Through a process of inventory control, manufacturers must maintain records of the 

entities to which they distribute the surgical masks and the numbers of each such 

product they distribute. 

E. Manufacturers must notify FDA of any authorized distributor(s) and/or authorized 

importers of the authorized surgical masks, including the name, address, and phone 

number of any authorized distributor(s) and authorized importer(s), and provide 

authorized distributor(s) and authorized importer(s) with a copy of this EUA and any 

updates. 

F. Manufacturers are authorized to make available additional information relating to the 

emergency use of the product that is consistent with, and does not exceed, the terms 

of this letter of authorization.

G. Manufacturers of authorized surgical masks must submit, upon FDA’s request, new 

lots of the authorized surgical masks for testing by FDA or by another entity 

designated by FDA. The manufacturers must not distribute any lot or shipment that 

fails testing, meaning the lot or shipment containing a lot that did not perform as 

expected based on the performance criteria in the Scope of Authorization (Section II). 

FDA will make the manufacturer aware of the testing results. 

Authorized Distributors and Authorized Importers16

H. Authorized Distributors and Authorized Importers must ensure that authorized 

surgical masks comply with condition A of this EUA. 

I. Through a process of inventory control, Authorized Distributors and Authorized 

Importers must maintain records of the entities to which they distribute the surgical 

masks and how many of each authorized product model they distribute or import, as 

applicable. 

J. Authorized Distributors and Authorized Importers must ensure that any records 

associated with this EUA are maintained until otherwise notified by FDA. Such 

records will be made available to FDA for inspection upon request. 

K. Authorized Distributors and Authorized Importers of authorized surgical masks must 

submit, upon FDA’s request, lots or shipments of the authorized surgical masks for 

testing by FDA or by another entity designated by FDA. Authorized Distributors and 

Authorized Importers must not distribute any lot or shipment that fails testing, 

meaning the lot or shipment containing a lot that did not perform as expected based 

on the performance criteria in the Scope of Authorization (Section II). FDA will make 

the Authorized Distributor or Authorized Importer aware of the testing results. 

16 “Authorized Distributor(s)” and “Authorized Importer(s)” are those that are identified by the manufacturer in

Condition of Authorization E. 
Page 8 

Conditions Related to Advertising and Promotion 

L. All descriptive printed matter, including advertising and promotional materials, 

relating to the use of the authorized surgical mask shall be consistent with the labeling 

requirements listed in Section II and this section (Conditions of Authorization) of this 

EUA, and meet the applicable requirements set forth in section 502(a) and (q)(1) and 

(r) of the Act, as applicable, and FDA implementing regulations. 

 

M. No descriptive printed matter, including advertising or promotional materials, relating 

to the use of the authorized surgical mask may represent or suggest that such product 

is safe or effective for the prevention or treatment of COVID-19. 

 

N. All descriptive printed matter, including advertising and promotional materials,

relating to the use of the product shall clearly and conspicuously state that: 

• The product has not been FDA cleared or approved. 

• The product has been authorized by FDA under an EUA for use in healthcare 

settings by HCP as PPE to provide a physical barrier to fluids and particulate 

materials to prevent HCP exposure to respiratory droplets and large particles 

during surgical mask shortages resulting from the COVID-19 pandemic. 

• This product is authorized only for the duration of the declaration that 

circumstances exist justifying the authorization of the emergency use of 

medical devices, including alternative products used as medical devices, 

during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. 

§ 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner. 

V. Duration of Authorization

This EUA will be effective until the declaration that circumstances exist justifying this

authorization is terminated under section 564(b)(2) of the Act or the EUA is revoked under 

section 564(g) of the Act. 

Sincerely,

____________________________ 

Jeffrey E. Shuren, M.D., J.D. 

Director

Center for Devices and Radiological Health

Food and Drug Administration