NIOSH Conformity Assessment Letter

to Manufacturers

NIOSH CA 2023-1058

MAY 16, 2023

 

Subject: Effective Immediately -- Revocation of Public Health Emergency 

(PHE) Approvals issued during the COVID-19 Response

Supersedes NIOSH CA 2022-1045
Document Number

NIOSH CA 2023-1058

Page 2 of 4

1) 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

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. 

Subject: Effective Immediately -- Revocation of Public Health Emergency (PHE) 

Approvals issued during the COVID-19 Response

Supersedes NIOSH CA 2022-1045
Document Number

NIOSH CA 2023-1058

Page 3 of 4

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Prior to May 11, 2023, 14 other PHE approvals were previously rescinded by the approval holder or 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

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

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
Document Number

NIOSH CA 2023-1058

Page 4 of 4

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 | CDC

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