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NIOSH Conformity Assessment Letter to Manufacturers

Subject: Effective Immediately — Revocation of Public Health Emergency (PHE) Approvals issued during the COVID-19 Response
Supersedes NIOSH CA 2022-1045

NIOSH CA 2023-1058
May 16, 2023

SUMMARY

Between May and November 2020, NIOSH issued limited, temporary Public Health Emergency (PHE) approvals for N95® filtering facepiece respirators (FFRs) and powered air-purifying respirators (PAPRs) to address supply shortages during that time. In July 2021, NIOSH published NIOSH CA 2021-1036 to remind PHE approval holders that these approvals are limited and temporary and will be revoked when the COVID-19 public health emergency declaration ends. In June 2022, NIOSH published NIOSH CA 2022-1044 and NIOSH CA 2022-1045, which obsoleted the remaining PHE approvals and advised users to phase-out the use of these respirators.  HHS Secretary Xavier Becerra issued a Statement on the End of the COVID-19 Public Health Emergency on May 11, 2023. May 11, 2023, marked the end of the U.S. federal COVID-19 PHE declaration.

Effectively immediately, NIOSH revokes eight PHE FFR approvals and four PHE PAPR approvals issued to the PHE approval holders listed in the table, below. These respirators are NO LONGER recognized as NIOSH Approved® respirators and therefore cannot be used, manufactured, sold, or distributed. Respirators bearing the NIOSH approval numbers listed below are no longer considered approved and may not be used in fulfillment of any standard or statute requiring the use of a NIOSH Approved respirator.

NIOSH REVOKED PHE FFR APPROVALS and APPROVAL HOLDERS
NIOSH REVOKED PHE FFR APPROVALS and APPROVAL HOLDERS
TC-84A-PH01 General Motors Company
TC-84A-PH04 General Motors Company
TC-84A-PH05 Ford Motor Company
TC-84A-PH06 ViruDefense Inc.
TC-84A-PH08 General Motors Company
TC-84A-PH15 Protective Health Gear, Inc.
TC-84A-PH16 Pandmedic, Inc.
TC-84A-PH18 Outdoor Research, LLC
NIOSH REVOKED PHE PAPR APPROVALS and APPROVAL HOLDERS
TC-21C-PH02 Ford Motor Company
TC-21C-PH03 Allegro Industries
TC-21C-PH05 AirBoss Defense Group, LLC
TC-21C-PH06 Hunter Engineering Company

Prior to May 11, 2023, 14 other PHE approvals were previously rescinded by the approval holder or revoked by NIOSH, as described in the table, below.  Revoked or rescinded respirators are NOT recognized as NIOSH-approved and cannot be used in workplace settings where the use of NIOSH-approved respirators is required.

RESCINDED or REVOKED PHE APPROVALS and APPROVAL HOLDERS PRIOR to May 11, 2023
RESCINDED or REVOKED PHE APPROVALS and APPROVAL HOLDERS PRIOR to May 11, 2023
TC-84A-PH02 Advoque Revoked 9/10/20
TC-84A-PH03  

Well Span Health

 

Rescinded 4/29/22

TC-84A-PH07
TC-84A-PH09 Outdoor Research, LLC Rescinded 9/29/20
TC-84A-PH10  

 

ThermoPore Materials Corporation

 

 

Rescinded 10/28/22

TC-84A-PH11
TC-84A-PH12
TC-84A-PH13
TC-84A-PH14
TC-84A-PH17 AmSafe Inc Rescinded 1/31/23
TC-84A-PH19 Plasticon Industries, LLC Revoked 4/18/21
TC-84A-PH20 United States Mask, LLC Rescinded 6/22/22
TC-21C-PH01 Whirlpool Corporation Rescinded 5/25/21
TC-21C-PH04 American PAPR, LLC Rescinded 12/5/22

The NIOSH certified equipment list identifies all active NIOSH Approved respirators.


N95® and NIOSH Approved® are registered certification marks of the U.S. Department of Health and Human Services (HHS)