Personal Protective Equipment EUAs
November 8, 2023 - 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Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.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. 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For information on EUAs that were previously issued but no longer in effect, including revoked EUAs, see Historical Information about Device Emergency Use Authorizations.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.
- EUA Letter of Authorization - Umbrella EUA for Surgical Masks (Reissued March 6, 2023)
- Fact Sheet for Healthcare Personnel
- Appendix A: Authorized Surgical Masks
- Surgical Masks Removed from 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 Addition | Manufacturer | Authorized Product Name (including model numbers) |
|---|---|---|
| 11/19/2021 | EcoGuard Inc. | Disposable Single Use 4-Ply Earloop, model EcoGuard A ECO05 |
| 10/29/2021 | MOCACARE Corporation | MOCACARE Surgical Mask (Level 3) Model number: BC1005 |
| 07/12/2021 | SurgiMac Manufacturing Inc. | Surgical Mask (Model – MAC-6501) |
| 06/30/2021 | Thrace Polyfilms S.A. | Surgical Masks Model PLF.IIR |
| 05/07/2021 | Altor Safety |
3 Ply Surgical Mask (Model # 62212) |
| 05/07/2021 | Health Pro Supplies Limited |
Medical Surgical Mask HP2723 (Large) Medical Surgical Mask HP9503 |
| 08/08/2020 | Outdoor Research | Outdoor Research Surgical Mask model #OR2159 |
| 08/18/2020 | Venus Group, Inc. | Venus Medical Grade Disposable Surgical Mask |
| 10/05/2020 | Hanesbrands, Inc. | Hanes Surgical Mask 01, Small and Large |
| 10/08/2020 | WPT Corporation | WPT ASTM F2100-19 Level 3 Earloop Surgical Face Mask (Model # SMS2020) |
| 10/15/2020 | Brandix Apparel Solutions Limited | Disposable Surgical Mask BRNDX-DSM-001-LARGE |
| 11/03/2020 | Fischer Manufacturing, LLC | Heartland Health Surgical Mask |
| 11/06/2020 | EcoGuard Inc. |
Surgical Mask - Disposable Single-Use 4-Ply Earloop Surgical Mask - Disposable Single-Use 4-Ply Tie-on |
| 11/20/2020 | Rymco Medical |
Surgical Mask (Tie-On) Surgical Mask (Earloop) |
| 12/09/2020 | Nomad Goods | Nomad Surgical Mask N-MASK-3 |
| 12/10/2020 | MOCACARE Corporation | MOCACARE Procedure Mask (Level 1) Model #: BC1003 |
| 01/22/2021 | Honeywell International Inc. | Procedure Mask with Earloops Model #: 559250M D |
| 01/29/2021 | 131co Inc. | ARX Surgical Mask (Model number ARX1001) |
| 02/12/2021 | SIO International Wisconsin, Inc | Sharp MQ-3050 Surgical mask; Foxconn MQ-3050 Surgical mask |
| 03/19/2021 | Cleveland Veteran Business Solutions | CVBS Surgical Mask - Model Number: SM1 |
| 03/29/2021 | Protektair, Inc | Protektair-3 Surgical Mask Model #: PSM-3000 |
| 03/30/2021 | PZero Innovations, Inc. | PZero Surgical Mask Model Number: FM20PZ00 |
| 04/06/2021 | Keeo Life Private Limited | 3PLY Surgical Mask KF-SM3-EL 4PLY Surgical Mask KF-SM4-EL |
| 04/19/2021 | BLUETRACK, Inc. | Healthcare Pro Surgical Masks S-3050-WH |
| 04/16/2021 | Manohar Filaments Private Limited | 3 Ply Surgical Mask MF-SM3-EH |
| 04/21/2021 | GRAFICA VENETA S.p.A. | MASK MEDICA GV 2 GV2-GVII-202007 |
| 04/28/2021 | Devshree International Pvt. Ltd. | Hoplon Brand Disposable Single Use Surgical Masks Level 1 per ASTM F2100 H3SS |
| 04/29/2021 | Phoenix Quality MFG, LLC | PQM LibertyAir Surgical MaskModel - S-9501-EUA |
| 04/29/2021 | Honeywell International Inc. | Procedure Mask with Earloops (PM345 C) |
| 04/29/2021 | Honeywell International Inc. | Procedure Mask with Earloops (PM345 D) |
| 04/29/2021 | Honeywell International Inc. | Procedure Mask with Earloops (PM345 E) |
| 05/12/2021 | Lumensource, LLC | Lumensource Surgical Mask Model # PKM-S201B |
| 05/21/2021 | Medtecs USA Corporation | Medtecs Medical Mask (Model FM-140G) |
| 05/21/2021 | Filtra-Systems Company, LLC | Filtra Systems Surgical Face Mask (Model number – 0605202) |
| 05/26/2021 | Linghe International co. Ltd. | Linghe Disposable, Single-Use Surgical Mask (Model Number: Best02) |
| 07/01/2021 | Connecticut Mask Company, LLC | CMC Surgical Mask 10 (Model - CMC 10; ASTM Level 1) CMC Surgical Mask 30 (Model - CMC30; ASTM Level 3) |
| 07/02/2021 | Sesa LLC | Sesa Health Surgical Mask (Model Number - SH.PPE.SM.2L3) |
| 07/02/2021 | LM Surgical Mask | 3-ply level 3 Earloop - LM0787 3-ply level 3 Head Straps - LM1019 |
| 10/28/2021 | DediCare Medical Solution LLC | Surgical Mask, Model Number – SM3101 |
| 11/05/2021 | Mahe Medical Service GmbH | Mahe Medical Disposable Surgical Face Mask with Earloops, Model 001-USA-E |
| 01/12/2022 | Sidra Medical Supply Inc. | Sidra Surgical Face Mask AD3PL2WH |
| 01/14/2022 | Little Rapids Corporation | Graham Medical® Surgical Masks – Model Numbers: 88037 & 88038 |
| 01/14/2022 | Supermax Healthcare Canada – Supermax Medical | Surgical Mask, Model Number – 2130 |
| 03/04/2022 | Supermax Healthcare Canada – Supermax Medical | Surgical Mask, Model Number – 2110 Surgical Mask, Model Number – 2120 |
| 01/18/2022 | SafeSource Direct, LLC | SafeSource Direct Surgical Mask with Ear Loops (Model EUA3001) |
| 06/30/2022 | Delta Medco, LLC | Delta Medco Disposable Surgical Face Mask with Earloops (Model DSM0001) |
| 07/07/2022 | ARCH MedTech, LLC | ARCH MedTech Level 3 Surgical Mask – AMT-001L (Earloop) ARCH MedTech Level 3 Surgical Mask – AMT-002T (Ear Ties) |
| 09/02/2022 | PADM Medical™ Procedural Masks with Ear loops | Surgical Mask, Model Number – SL3P1710 |
| 02/07/2023 | Medplan Private Limited | MED-2002-EL (50 pieces/box) |
| 02/09/2023 | MDT Medical Products | MDT 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 |
Manufacturer | Surgical Mask Model(s) No Longer Authorized |
|---|---|---|
| 01/21/2021 | Premier Guard USA LLC | Premier Guard USA Surgical Face Mask 20-1002-SFM3 |
| 02/02/2021 | EcoGuard Inc. |
Surgical Mask - Disposable Single-Use 3-Ply Earloop Surgical Mask - Disposable Single-Use 3-Ply Tie-on |
| 03/19/2021 | Homtex, Inc. | Sovereign America Surgical Mask Model #: 2000SM1, Blue color |
| 06/15/2021 | Premium-PPE Amerishield | Premium PPE Amerishield Disposable Surgical Mask Model #: PPE-M-AS-SUR-lvl2-S |
| 07/23/2021 | Altor Safety | 3 Ply Surgical Mask (Model #62222) |
| 09/03/2021 | Altor Safety | 4 Ply Surgical Mast (Model #62232) |
| 03/30/2022 | INTAI Technology CORP |
INTAI SURGICAL MASK (non-sterile) - ASTM Level3 INTAI SURGICAL MASK (non-sterile) - ASTM Level3 |
| 12/16/2021 | Liberty Mask, LLC |
LM Surgical Mask Level 3
|
| 06/14/2023 | PADM Medical Inc. | PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops (black - 100195, white - 100196) |
| 09/27/2023 | KNH 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) |
| 09/27/2023 | Honeywell International Inc. | Procedure Mask with Earloops Model #: 559250M, 559250M B and 559250M C |
| 09/27/2023 | Danameco Medical Joint Stock Corporation | D-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 Issued | PPE (Letter of Authorization) | Other Documents |
|---|---|---|
| 03/28/2020 | NIOSH-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 Issued | PPE (Letter of Authorization) | Other Documents | Procode Assigned |
|---|---|---|---|
| 05/04/2021 | ISOCUBE SS and ISOCUBE ONE | QLE | |
| 04/09/2020 | Face Shields |
|
QPK |
| 05/08/2020 | Patient Isolation Transport Unit (PITU) Device | QLE | |
| 05/27/2020 | Gowns and Other Apparel |
|
QZT |
| 06/13/2020 | Negative-pressure Respiratory System with Advanced Ventilation Return (NRSAVR-100) | QLE | |
| 07/24/2020 | Airway Dome | QLE | |
| 09/24/2020 | COVIAGE | QLE | |
| 12/18/2020 | SCONE (Re-issued 04/12/2021) |
QLE | |
| 03/29/2021 | AerosolVE Device (Revised Labeling 06/11/2021) |
QLE | |
| 04/01/2021 | Individual Biocontainment Unit (IBU) (Revised Labeling 09/08/2021) |
QLE | |
| 04/13/2020 | Airborne Isolation Hood Device | QLE | |
| 05/06/2021 | Negative 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 Issued | Date of Withdrawal | PPE (Letter of Authorization) | Other Documents | Procode Assigned |
|---|---|---|---|---|
| 05/19/2020 | 12/19/2022 |
COVID-19 Airway Management Isolation Chamber (CAMIC) |
QLE |