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  7. Personal Protective Equipment EUAs
  1. COVID-19 Emergency Use Authorizations for Medical Devices

Personal Protective Equipment EUAs

August 11, 2026 - The COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired on May 11, 2023. The COVID-19 enforcement policy guidances within scope of the Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.

The end of the COVID-19 PHE and certain COVID-19 enforcement policy guidances no longer being in effect do not impact the FDA's ability to authorize devices, including tests, for emergency use. Existing emergency use authorizations (EUAs) for devices relating to COVID-19 remain in effect under section 564 of the Federal Food, Drug, and Cosmetic Act.

On June 29, 2026, the HHS Secretary determined that circumstances no longer exist justifying the authorization of emergency use of (1) in vitro diagnostics for detection and/or diagnosis of the SARS-CoV-2 virus; (2) personal respiratory protective devices; and (3) medical devices, including alternative products used as medical devices. On the basis of this determination, the HHS declarations authorizing emergency use of these medical devices for COVID-19 will be terminated, effective December 26, 2026. On the effective date of this termination, the COVID-19 emergency use authorizations (EUA) for devices currently listed on this website will no longer be in effect.  

The FDA encourages manufacturers of devices issued EUAs related to COVID-19 to review the guidance: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19), which outlines the FDA's recommendations and expectations to such manufacturers to transition to normal operations when the declarations that allowed for FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act end. Additional information is provided on the page FAQs: What happens to EUAs when a public health emergency ends?

Personal Protective Equipment (PPE) refers to protective clothing, helmets, gloves, face shields, goggles, respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness.

To help address concerns about availability during the COVID-19 pandemic, the FDA has issued Emergency Use Authorizations (EUAs) for certain PPE products including face shields, other barriers, and respiratory protective devices such as respirators. Additionally, the FDA has issued recommendations and policies about PPE which can be found here: Guidance Documents (Medical Devices and Radiation-Emitting Products).

Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including an Interactive Review Template For Non-IVD Products.

Table of Personal Protective Equipment (PPE) EUAs

For information on EUAs that were previously issued but no longer in effect, including revoked EUAs, see Historical Information about Device Emergency Use Authorizations.

Umbrella EUA for Surgical Masks

On August 5, 2020, the FDA issued an umbrella EUA for certain disposable, single-use surgical masks in response to concerns relating to insufficient supply and availability of such masks. This EUA authorized the emergency use of surgical masks that met certain performance requirements for use in healthcare settings by health care personnel (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 that have been confirmed by FDA to meet the criteria under the EUA are included below in Appendix A as authorized surgical masks.

On March 6, 2023, the FDA revised and reissued the umbrella EUA for disposable, single-use surgical masks intended for use in health care settings by health care professionals during the COVID-19 pandemic. The revision authorizes emergency use of only those surgical masks listed in the EUA’s Appendix A as of the date of this reissuance. As a result of this revision, the FDA will no longer add surgical masks to Appendix A.

Appendix A: Authorized Surgical Masks

The table below includes a list of surgical masks authorized by this Umbrella EUA for emergency use during the COVID-19 public health emergency.

All authorized surgical masks in the table below (Appendix A) are assigned the QMF product code.

Date of AdditionManufacturerAuthorized Product Name (including model numbers)
11/19/2021EcoGuard Inc.Disposable Single Use 4-Ply Earloop, model EcoGuard A ECO05
10/29/2021MOCACARE CorporationMOCACARE Surgical Mask (Level 3)
Model number: BC1005
07/12/2021SurgiMac Manufacturing Inc.Surgical Mask (Model – MAC-6501)
06/30/2021Thrace Polyfilms S.A.Surgical Masks Model PLF.IIR
05/07/2021Altor Safety3 Ply Surgical Mask (Model # 62212)
05/07/2021Health Pro Supplies Limited

Medical Surgical Mask HP2723 (Large)

Medical Surgical Mask HP9503  

08/08/2020Outdoor ResearchOutdoor Research Surgical Mask model #OR2159
08/18/2020Venus Group, Inc.Venus Medical Grade Disposable Surgical Mask
10/05/2020Hanesbrands, Inc.Hanes Surgical Mask 01, Small and Large
10/08/2020WPT CorporationWPT ASTM F2100-19 Level 3 Earloop Surgical Face Mask (Model # SMS2020)
10/15/2020Brandix Apparel Solutions LimitedDisposable Surgical Mask BRNDX-DSM-001-LARGE
11/03/2020Fischer Manufacturing, LLCHeartland Health Surgical Mask
11/06/2020EcoGuard Inc.

Surgical Mask - Disposable Single-Use 4-Ply Earloop
Model #: EcoGuard A ECO03

Surgical Mask - Disposable Single-Use 4-Ply Tie-on
Model #: EcoGuard A ECO04

11/20/2020Rymco Medical

Surgical Mask (Tie-On)
Model #: IMABEU

Surgical Mask (Earloop)
Model #: IMSBEU

12/09/2020Nomad GoodsNomad Surgical Mask N-MASK-3
12/10/2020MOCACARE CorporationMOCACARE Procedure Mask (Level 1)
Model #: BC1003
01/22/2021Honeywell International Inc.Procedure Mask with Earloops
Model #: 559250M D
01/29/2021131co Inc.ARX Surgical Mask (Model number ARX1001)
02/12/2021SIO International Wisconsin, IncSharp MQ-3050 Surgical mask; Foxconn MQ-3050 Surgical mask
03/19/2021Cleveland Veteran Business SolutionsCVBS Surgical Mask - Model Number: SM1
03/29/2021Protektair, IncProtektair-3 Surgical Mask Model #: PSM-3000
03/30/2021PZero Innovations, Inc.PZero Surgical Mask Model Number: FM20PZ00
04/06/2021Keeo Life Private Limited3PLY Surgical Mask KF-SM3-EL
4PLY Surgical Mask KF-SM4-EL
04/19/2021BLUETRACK, Inc.Healthcare Pro Surgical Masks
S-3050-WH
04/16/2021Manohar Filaments Private Limited 3 Ply Surgical Mask
MF-SM3-EH
04/21/2021GRAFICA VENETA S.p.A.MASK MEDICA GV 2 GV2-GVII-202007
04/28/2021Devshree International Pvt. Ltd.Hoplon Brand Disposable Single Use Surgical Masks Level 1 per ASTM F2100 H3SS
04/29/2021Phoenix Quality MFG, LLCPQM LibertyAir Surgical MaskModel - S-9501-EUA
04/29/2021Honeywell International Inc.Procedure Mask with Earloops (PM345 C)
04/29/2021Honeywell International Inc.Procedure Mask with Earloops (PM345 D)
04/29/2021Honeywell International Inc.Procedure Mask with Earloops (PM345 E)
05/12/2021Lumensource, LLCLumensource Surgical Mask Model # PKM-S201B
05/21/2021Medtecs USA CorporationMedtecs Medical Mask (Model FM-140G)
05/21/2021Filtra-Systems Company, LLCFiltra Systems Surgical Face Mask (Model number – 0605202)
05/26/2021Linghe International co. Ltd.Linghe Disposable, Single-Use Surgical Mask (Model Number: Best02)
07/01/2021Connecticut Mask Company, LLCCMC Surgical Mask 10 (Model - CMC 10; ASTM Level 1)
CMC Surgical Mask 30 (Model - CMC30; ASTM Level 3)
07/02/2021Sesa LLCSesa Health Surgical Mask (Model Number - SH.PPE.SM.2L3)
07/02/2021LM Surgical Mask3-ply level 3 Earloop - LM0787
3-ply level 3 Head Straps - LM1019
10/28/2021DediCare Medical Solution LLCSurgical Mask, Model Number – SM3101
11/05/2021Mahe Medical Service GmbHMahe Medical Disposable Surgical Face Mask with Earloops, Model 001-USA-E
01/12/2022Sidra Medical Supply Inc.Sidra Surgical Face Mask AD3PL2WH
01/14/2022Little Rapids CorporationGraham Medical® Surgical Masks – Model Numbers: 88037 & 88038
01/14/2022Supermax Healthcare Canada – Supermax MedicalSurgical Mask, Model Number – 2130
03/04/2022Supermax Healthcare Canada – Supermax MedicalSurgical Mask, Model Number – 2110
Surgical Mask, Model Number – 2120
01/18/2022SafeSource Direct, LLCSafeSource Direct Surgical Mask with Ear Loops (Model EUA3001)
06/30/2022Delta Medco, LLCDelta Medco Disposable Surgical Face Mask with Earloops (Model DSM0001)
07/07/2022ARCH MedTech, LLCARCH MedTech Level 3 Surgical Mask – AMT-001L (Earloop)
ARCH MedTech Level 3 Surgical Mask – AMT-002T (Ear Ties)
09/02/2022PADM Medical™ Procedural Masks with Ear loopsSurgical Mask, Model Number – SL3P1710
02/07/2023Medplan Private LimitedMED-2002-EL (50 pieces/box)
02/09/2023MDT Medical ProductsMDT Medical Products 3PLY Mask

Surgical Masks Removed from Appendix A

These surgical mask models had been on the list of authorized surgical masks in Appendix A but no longer meet the EUA's scope of authorization and thus are no longer authorized and have accordingly been removed from Appendix A.

Date No
Longer
Authorized		ManufacturerSurgical Mask Model(s) No Longer Authorized
01/21/2021Premier Guard USA LLCPremier Guard USA Surgical Face Mask 20-1002-SFM3
02/02/2021EcoGuard Inc.

Surgical Mask - Disposable Single-Use 3-Ply Earloop
Model #: EcoGuard B ECO01

Surgical Mask - Disposable Single-Use 3-Ply Tie-on
Model #: EcoGuard B ECO02

03/19/2021Homtex, Inc.Sovereign America Surgical Mask
Model #: 2000SM1, Blue color
06/15/2021Premium-PPE AmerishieldPremium PPE Amerishield Disposable Surgical Mask Model #: PPE-M-AS-SUR-lvl2-S
07/23/2021Altor Safety3 Ply Surgical Mask (Model #62222)
09/03/2021Altor Safety4 Ply Surgical Mast (Model #62232)
03/30/2022INTAI Technology CORP

INTAI SURGICAL MASK (non-sterile) - ASTM Level3
(Model 9W001200)

INTAI SURGICAL MASK (non-sterile) - ASTM Level3
(Model 9W001201)

12/16/2021Liberty Mask, LLC

LM Surgical Mask Level 3


LM Surgical Mask Level 2

06/14/2023PADM Medical Inc.PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops (black - 100195, white - 100196) 
09/27/2023KNH Enterprise Co., Ltd.KNH Surgical Face Mask 
Model Numbers:  
902E1 (Ear Loop Level 1 – inner loop) 
902E1-1 (Ear Loop Level 1 – outer loop) 
902E2 (Ear Loop Level 2 – inner loop) 
902E2-1 (Ear Loop Level 2 – outer loop) 
902D1-M (3D Level 1 – size M) 
902D1-L (3D Level 1 – size L) 
902D2-M (3D Level 2 – size M) 
902D2-L (3D Level 2 – size L) 
902Z1 (Z-Folded Level 1) 
902Z1 (Z-Folded Level 2)
09/27/2023Honeywell International Inc.Procedure Mask with Earloops
Model #: 559250M, 559250M B and 559250M C
09/27/2023Danameco Medical Joint Stock CorporationD-Care Surgical Face Mask 3 ply (white), TAMMY Surgical Face Mask 3 ply (white)
Model/AMIS Numbers: KTY60WK050, KTY75WK050, KTY74WK050

N95 and Other Respirators EUAs

The table below includes information about respirators authorized for emergency use by healthcare personnel during the COVID-19 public health emergency.

Date EUA IssuedPPE (Letter of Authorization)Other Documents
03/28/2020NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency

Face Shields and Other Barrier EUAs

Face shields and other barriers are a type of PPE intended to protect the user from bodily fluids, liquid splashes, or potentially infectious materials. Availability of certain PPE are an integral part of routine patient care during the COVID-19 pandemic. The table below includes authorization information about the use of authorized face shields and other barriers for use during the COVID-19 public health emergency.

Date EUA IssuedPPE (Letter of Authorization)Other DocumentsProcode Assigned
05/04/2021ISOCUBE SS and ISOCUBE ONEQLE
04/09/2020Face Shields
  • None
QPK
05/08/2020Patient Isolation Transport Unit (PITU) DeviceQLE
05/27/2020Gowns and Other Apparel
  • None
QZT
06/13/2020Negative-pressure Respiratory System with Advanced Ventilation Return (NRSAVR-100)QLE
07/24/2020Airway DomeQLE
09/24/2020COVIAGEQLE
12/18/2020SCONE
(Re-issued 04/12/2021)		QLE
03/29/2021AerosolVE Device
(Revised Labeling 06/11/2021)		QLE
04/01/2021Individual Biocontainment Unit (IBU)
(Revised Labeling 09/08/2021)		QLE
04/13/2020Airborne Isolation Hood DeviceQLE
05/06/2021Negative Pressure SteriDome (NPS)QLE

Withdrawal Due to Other Reasons

The personal protective equipment on this list have been withdrawn at the request of the EUA holder and thus are no longer authorized and have accordingly been removed from the list of authorized EUAs above.

Date EUA IssuedDate of WithdrawalPPE (Letter of Authorization)Other DocumentsProcode Assigned
05/19/202012/19/2022COVID-19 Airway Management Isolation Chamber (CAMIC)
(Reissued 06/22/2020)		QLE
If you have a question about:Send email to:
Masks, including surgical masksCDRH-COVID19-SurgicalMasks@fda.hhs.gov
Respirators, including N95 and KN95 respiratorsCDRH-COVID19-SurgicalMasks@fda.hhs.gov

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