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NIOSH Conformity Assessment Letter to Manufacturers						Print
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										**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Prior to May 11, 2023, 14 other PHE approvals were previously rescinded by the approval holder or revoked by NIOSH, as described in the table, below.  Revoked or rescinded respirators are NOT recognized as NIOSH-approved and cannot be used in workplace settings where the use of NIOSH-approved respirators is required.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.AUTHORITY
42 C.F.R. Part 84, Approval of Respiratory Protective Devices
REFERENCES
End of the Federal COVID-19 Public Health Emergency (PHE) Declaration | CDC
Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap | HHS.gov
Fact Sheet: End of the COVID-19 Public Health Emergency | HHS.gov
NIOSH Conformity Assessment Letter to Manufacturers (CA 2021-1036) | NPPTL | NIOSH | CDC
NIOSH Respiratory Protective Device Information (CA 2022-1044) | NPPTL | NIOSH | CDC
NIOSH Conformity Assessment Letter to Manufacturers (CA 2022-1045) | NPPTL | NIOSH | CDCEffective Immediately-Revocation of Public Health Emergency (PHE) Approvals issued during the COVID-19 Response. Supersedes NIOSH CA 2022-1045[PDF – 213 KB]N95® and NIOSH Approved® are registered certification marks of the U.S. Department of Health and Human Services (HHS)
							
					
							Last Reviewed:  May 17, 2023						Source: 	National Institute for Occupational Safety and Health
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