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  7. Personal Protective Equipment EUAs
  1. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

Personal Protective Equipment EUAs

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: Recent Final Medical Device Guidance Documents.

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. Additionally, the FDA has posted a Surgical Masks EUA Template for Addition to Appendix A of the Surgical Mask Umbrella EUA.

Table of Personal Protective Equipment (PPE) EUAs

FDA Revokes Emergency Use Authorizations for Non-NIOSH-Approved Disposable Respirators and Decontamination Systems as Access to FDA-authorized and NIOSH-approved N95s Increases Nationwide

On June 30, 2021, the FDA announced the revocation of the following EUAs:

As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings. For additional information, please see Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities.

Historical information regarding these EUAs can be found on 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.

The Surgical Masks EUA Template for Addition to Appendix A can be used to provide the information requested in the EUA to the FDA.

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)
07/16/2021 INTAI Technology CORP

9W001200 (50 pieces/box)

9W001201 (30 boxes/carton)

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)

4 Ply Surgical Mask (Model #62232)

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
Model #: EcoGuard A ECO03

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

11/20/2020 Rymco Medical

Surgical Mask (Tie-On)
Model #: IMABEU

Surgical Mask (Earloop)
Model #: IMSBEU

12/09/2020 Nomad Goods Nomad Surgical Mask N-MASK-3
12/10/2020 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
12/10/2020 MOCACARE Corporation MOCACARE Procedure Mask (Level 1)
Model #: BC1003
12/16/2020 Honeywell International Inc. Procedure Mask with Earloops
Model #: 559250M
12/19/2020 Honeywell International Inc. Procedure Mask with Earloops
Model #: 559250M B and 559250M C
01/22/2021 Honeywell International Inc. Procedure Mask with Earloops
Model #: 559250M D
01/19/2021 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)

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

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
01/22/2021 Premier Guard USA LLC Premier Guard USA Surgical Face Mask 20-1002-SFM3
02/03/2021 EcoGuard 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

03/19/2021 Homtex, Inc. Sovereign America Surgical Mask
Model #: 2000SM1, Blue color
07/06/2021 Premium-PPE Amerishield Premium PPE Amerishield Disposable Surgical Mask Model #: PPE-M-AS-SUR-lvl2-S
07/24/2021 Altor Safety 3 Ply Surgical Mask (Model #62222)

N95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)

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


Face Shields and Other Barrier EUAs

On May 1, 2020, the FDA issued an umbrella EUA for emergency use of protective barrier enclosures by HCP when caring for or performing medical procedures on patients who are known or suspected to have COVID-19 in health care settings to prevent HCP exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to PPE. The authorization of a device for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act, be revised or revoked when the criteria under section 564(b)(1) of the Act no longer exist, the criteria under section 564(c) of the Act for issuance of such authorization are no longer met, or other circumstances make such revision or revocation appropriate to protect the public health or safety.

On August 20, 2020, based on FDA's continued review of the scientific evidence available, the FDA revoked the umbrella EUA on the grounds that the criteria under section 564(c) of the Act for issuance of an EUA are no longer met and that revocation was appropriate to protect the public health or safety (see section 564(g)(2)(B)&(C) of the Act), and that individualized consideration of each EUA request for protective barrier enclosures would better protect the public health.

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
  • None
QPK
05/08/2020 Patient Isolation Transport Unit (PITU) Device QLE
05/27/2020 Gowns and Other Apparel
  • None
QPK
06/13/2020 Negative-pressure Respiratory System with Advanced Ventilation Return (NRSAVR-100) QLE
05/19/2020

COVID-19 Airway Management Isolation Chamber (CAMIC)
(Reissued 06/22/2020)

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) QLE
04/13/2020 Airborne Isolation Hood Device QLE
05/06/2021 Negative Pressure SteriDome (NPS) QLE

 

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