NIOSH just released this summary of issues with foreign manufactured respirators.
Facial coverings ("non-respirators") continue to be recommended by CDC for COVID-19 community spread prevention. This guidance pertains to respirators when they are used (required or voluntary use).
Resources for International and Counterfeit Respirator Issues
NIOSH-approved respirators provide users with the confidence that the device will provide the expected level of protection, as long as it fits properly and is worn correctly. Due to current shortages of NIOSH-approved filtering facepiece respirators (FFRs), other reliable options must be found.
When possible, NIOSH recommends the use of NIOSH-approved reusable elastomeric respirators and powered air-purifying respirators (PAPRs) as alternatives to FFRs. When a facility still needs additional FFRs, the CDC and the U.S. Food and Drug Administration (FDA) have determined that other options may be appropriate to protect workers during the pandemic. One of these options is to purchase respirators that meet the regulatory requirements of the countries listed in the FDA's Emergency Use Authorization (EUA)*.
However, due to the current demand, buyers should be aware that an unprecedented number of products on the market do not perform as advertised and/or may be counterfeit.
Below are resources on how to evaluate respirators from other countries to determine if they are counterfeit or provide substandard protection:
- Factors to Consider When Planning to Purchase Respirators From Another Country, Including KN95 Respirators From China and Understanding the Use of Imported Non-NIOSH-Approved Respirators
- NIOSH Webinar: Factors to Consider When Planning to Purchase Respirators From Another Country
- Counterfeit Respirators/Misrepresentation of NIOSH Approval
- NIOSH Certified Equipment List
- NIOSH-Approved Respirator Markings and Approval Labels