NIOSH Respiratory Protective Device Information

NIOSH CA 2022-1044

June 2022

 

Immediate information for respirator users regarding NIOSH Public Health 

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

action to obsolete (phase out) these PHE approvals
Document Number

NIOSH CA 2022 – 1044

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 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 PHEapproved) 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. 

Immediate information for respirator users regarding NIOSH Public Health 

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

obsolete (phase out) these PHE approvals
Document Number

NIOSH CA 2022 – 1044

Page 3 of 4

2) 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
Document Number

NIOSH CA 2022 – 1044

Page 4 of 4

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 NIOSHapproved 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

3) AUTHORITY

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

4) 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)