Certain respirators made in China may not provide consistent and adequate respiratory protection to healthcare workers exposed to COVID-19, FDA said after a number of these devices failed to demonstrate a minimum particulate filtration efficiency of 95% in testing.
The testing was conducted by the National Institute for Occupational Safety and Health (NIOSH) - National Personal Protective Technology Laboratory of the Centers for Disease Control and Prevention. Based on the NIOSH testing, FDA revised and reissued its earlier 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 FDA by the manufacturer or importer – and accordingly removed from Appendix A the devices that had been authorized under that criterion, regardless of whether they passed or failed the NIOSH testing.
Devices that were removed from Appendix A of the EUA and that did not meet their labeled performance standard are no longer eligible and are no longer authorized to be marketed or distributed in the United States as respirators. However, FDA said the devices may be re-labled as face masks and authorized if certain criteria are met under the face mask umbrella EUA.
Non-NIOSH-approved respirators that meet the other eligibility criteria in the reissued EUA remain authorized by FDA for use during the COVID-19 pandemic and continue to be listed in Appendix A.