The US Food and Drug Administration (FDA) is concerned that some filtering facepiece respirators from China are not providing consistent and adequate respiratory protection to healthcare workers exposed to COVID-19.
From the US FDA:
On May 7, 2020, the FDA reissued the Emergency Use Authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China to revise one of the eligibility criteria – the criterion for authorization of respirators based on review of test reports from recognized independent test laboratories submitted to the FDA by the manufacturer or importer – and accordingly removed from Appendix A the respirators that had been authorized under that criterion, regardless of whether they passed or failed the NIOSH testing. …
Respirators that were removed from Appendix A of the EUA and that did not meet their labeled performance standard (listed below) are no longer eligible and are no longer authorized to be marketed or distributed in the United States as respirators. They may be re-labeled as face masks and authorized if certain criteria are met under the Face Mask umbrella EUA.
