NIOSH Respiratory Protective Device Information

NIOSH CA 2023-1059

May 16, 2023

 

Subject: Effective Immediately -- Revocation of NIOSH Public Health 

Emergency (PHE) Approvals issued during the COVID-19 Response 

Supersedes NIOSH CA 2022-1044
Document Number

NIOSH CA 2023 – 1059

Page 2 of 4

 

1) SUMMARY

Between May and November 2020, the National Institute for Occupational Safety and Health (NIOSH) 

issued limited, temporary Public Health Emergency (PHE) approvals for N95® filtering facepiece 

respirators (FFRs) and powered air-purifying respirators (PAPRs) to address respirator 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 in workplace settings that require the use 

of NIOSH Approved respirators. Respirators bearing the NIOSH approval numbers listed below are no 

longer considered approved and may not be used to fulfill any standard or statute requiring the use of 

a NIOSH Approved respirator.

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.

Subject: Effective Immediately -- Revocation of NIOSH Public Health Emergency 

(PHE) Approvals issued during the COVID-19 Response 

Supersedes NIOSH CA 2022-1044
Document Number

NIOSH CA 2023 – 1059

Page 3 of 4

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 NIOSHapproved respirators is required. 

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

Note: PHE-approved FFRs and PAPRs are easily recognized by the approval number assigned (TC-84APHXX or TC-21C-PHXX) and the NIOSH approval label, which includes the caution and limitation PH: 

The limited FFR approval will be effective until the declaration that circumstances exist justifying the 

authorization of the emergency use of personal respiratory protective devices during the COVID-19 

outbreak is terminated under Section 564(b)(2) of the Act, or the EUA is revoked under Section 564(g) of 

the Act, or until such time that the approved configuration can no longer be maintained. 

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

NIOSH CA 2023 – 1059

Page 4 of 4

2) AUTHORITY

42 C.F.R. Part 84, Approval of Respiratory Protective Devices

3) 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

Occupational Safety and Health Administration, Personal Protective Equipment, Respiratory 

Protection. 1910.134 - Respiratory protection. | Occupational Safety and Health Administration 

(osha.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 | CDC

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