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NIOSH Conformity Assessment Letter to Manufacturers
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 | |
| 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Prior to May 11, 2023, 14 other PHE approvals were previously rescinded by the approval holder or revoked by NIOSH, as described in the table, below. Revoked or rescinded respirators are NOT recognized as NIOSH-approved and cannot be used in workplace settings where the use of NIOSH-approved respirators is required.
| RESCINDED or REVOKED PHE APPROVALS and APPROVAL HOLDERS PRIOR to May 11, 2023 | ||
| 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 | CDC
N95® and NIOSH Approved® are registered certification marks of the U.S. Department of Health and Human Services (HHS)