NIOSH Respiratory Protective Device Information
Updated April 20, 2020
NIOSH CA 2020-1026
Revised April 2020
Based on the COVID-19 response and numerous inquiries regarding potentially noncompliant NIOSH-approved N95 respirators, NIOSH is issuing this notice to alert users about potential counterfeit products. Specifically, NIOSH is concerned about FFRs misrepresented as “Shanghai Dasheng,” “Dasheng,” or “Raxwell” NIOSH-approved N95 respirators. These models include, but may not be limited to, models DTC3X (marked as TC-84A-4329), DTC3W (marked as TC-84A-4335), DTC3B (marked as TC-84A-4336), and Raxwell RX9501P. Reports of counterfeit respirators or respirators misrepresented as NIOSH-approved are reviewed and, if confirmed, are posted on the Counterfeit Respirators/Misrepresentation of NIOSH Approval webpage.
NIOSH approvals issued to Shanghai Dasheng Health Products Manufacture Co., Ltd. (SDH) are for respirators that include two headbands, not ear loops, to secure the respirator to the face. NIOSH has received reports stating there is product being obtained directly from the Shanghai Dasheng factory, labeled as NIOSH-approved, with ear loops.
In accordance with the NIOSH regulation, 42 CFR Part 84, Approval of Respiratory Protective Devicesexternal icon, any changes a manufacturer wishes to make to NIOSH-approved respirators must first be evaluated and approved by NIOSH. Switching from headbands to ear loops is typical of the type of change requiring prior notice and approval by NIOSH; therefore, the modified respirators are not NIOSH-approved.
NIOSH has been communicating with Shanghai Dasheng Health Products Manufacture Co., Ltd. (SDH) and users concerned about this situation. NIOSH is also pursuing further actions to mitigate the situation. If you have any questions, please contact ppeconcerns@cdc.gov.