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NIOSH Respiratory Protective Device Information
NIOSH CA 2022-1044
June 2022
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 respirator supply shortages during that time.
The PHE-approved respirators are easily recognized by the assigned approval number, which includes the designation “PH.” PHE-approved FFRs are marked TC-84A-PHXX and PHE-approved PAPRs are marked TC-21C-PHXX, and both are easily identified on the NIOSH Certified Equipment List (CEL). These respirators were approved for immediate use during the early months of the pandemic and were NOT intended for creating or replenishing stockpiles.
Because there are adequate supplies of conventional NIOSH-approved respirators (not PHE-approved) in the United States, effective immediately, the 14 active FFR PHE and 5 active PAPR PHE approvals are obsolete. Obsoleted respirators are no longer permitted to be manufactured by the approval holder but can continue to be sold, used, and recognized as NIOSH-approved.
Users in workplace settings that require the use of NIOSH-approved respirators may continue to use the obsoleted PHE-approved FFRs and PAPRs until the COVID-19 public health emergency ends.
All PHE approvals listed below will remain in the obsoleted status on the CEL until the COVID-19 public health emergency ends, unless there is an action by the approval holder to change that status more quickly. Once the public health emergency ends, the obsoleted approvals will be revoked by NIOSH, meaning they are no longer recognized as NIOSH-approved and cannot be used in workplace settings where the use of NIOSH-approved respirators is required.
By obsoleting the PHE-approved FFRs and PAPRs now, users have time to exhaust any remaining supply of PHE-approved respirators and can plan to purchase other (non-PHE) NIOSH-approved respirators.
NIOSH-approved respirators can be identified using the NIOSH CEL. The current status of the PHE approvals for PAPRs and FFRs can also be checked using the CEL.
SUPPLEMENTAL INFORMATION
The table provided below clearly identifies the obsoleted PHE FFRs and PAPRs with the assigned PHE approval holders.
PHE-approved FFRs and PAPRs are easily recognized by the approval number assigned (TC-84A-PHXX 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.
| OBSOLETED 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-PH10 | ThermoPore Materials Corporation |
| TC-84A-PH11 | ThermoPore Materials Corporation |
| TC-84A-PH12 | ThermoPore Materials Corporation |
| TC-84A-PH13 | ThermoPore Materials Corporation |
| TC-84A-PH14 | ThermoPore Materials Corporation |
| TC-84A-PH15 | Protective Health Gear, Inc. |
| TC-84A-PH16 | Pandmedic, Inc. |
| TC-84A-PH17 | AmSafe Inc. |
| TC-84A-PH18 | Outdoor Research, LLC |
| OBSOLETED PHE PAPR APPROVALS and APPROVAL HOLDERS | |
|---|---|
| TC-21C-PH02 | Ford Motor Company |
| TC-21C-PH03 | Allegro Industries |
| TC-21C-PH04 | American PAPR, LLC |
| TC-21C-PH05 | AirBoss Defense Group, LLC |
| TC-21C-PH06 | Hunter Engineering Company |
The table provided below identifies seven other PHE approvals previously rescinded by the approval holder or revoked by NIOSH. 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 | ||
|---|---|---|
| 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-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 |
AUTHORITY
42 C.F.R. Part 84, Approval of Respiratory Protective Devices
REFERENCES
Reference Public Health Emergency Declarations for the most current Renewal of the Determination that a Public Health Emergency Exists Nationwide as the Result of the Continued Consequences of Coronavirus Disease 2019 (COVID-19) Pandemic.
NIOSH Conformity Assessment Letter to Manufacturers (CA 2021-1036) | NPPTL | NIOSH | CDC, Immediate Information for NIOSH-Approval Holders having Public Health Emergency (PHE) Approvals issued during the COVID-19 Response, and the forthcoming NIOSH revocation of these PHE approvals.
Occupational Safety and Health Administration, Personal Protective Equipment, Respiratory Protection. 1910.134 – Respiratory protection. | Occupational Safety and Health Administration (osha.gov)