FDA removes Emergency Masks failed to demonstrate at least 95% particulate filtration efficiency
The U.S. Food and Drug Administration has removed its Emergency Use Authorization for several KN95 masks, which are made in China after they failed to meet a minimum particulate filtration efficiency of 95% in the National Institute for Occupational Safety and Health testing.
During a public health emergency, the FDA can authorize the use of medical products that have not gone through the regular approval process, as well as the off-label use of medical products that previously were approved for other uses. The FDA can grant Emergency Use Authorization for devices or medications used to diagnose, treat or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives, according to its website.
In response to continued mask shortages, the FDA issued an Emergency Use Authorization on April 3 for several makes and models of KN95 masks, making them eligible for use as respirators if they met the necessary criteria. However, the agency revised and reissued the authorization on May 7 because of concerns about the authenticity of masks that were approved for use based on test reports submitted to the FDA by the manufacturer or importer of the masks. The testing had been performed by recognized independent test laboratories.
Some KN95 masks that initially were authorized failed subsequent National Institute for Occupational Safety and Health testing and cannot be relied upon as respirators. These include masks manufactured by:
• CTT Co. Ltd.
• Daddybaby Co. Ltd.
• Dongguan Xianda Medical Equipment Co. Ltd.
• Guangdong Fei Fan Mstar Technology Ltd.
• Guangdong Nuokang Medical Technology Co. Ltd.
• Huizhou Huinuo Technology Co. Ltd.
• Lanshan Shendun Technology Co.
The remaining KN95 masks that demonstrated at least 95% filtration efficiency remain authorized for emergency use as respirators.
For a full list of personal protective equipment authorized for emergency use by the FDA, go to the agency’s Emergency Use Authorizations webpage.
To learn more about factors to consider when purchasing masks from another country, including KN95 masks, visit the Centers for Disease Control and Prevention website.
The U.S. Food and Drug Administration (FDA) is concerned that certain filtering facepiece respirators (respirators) from China may not provide consistent and adequate respiratory protection to health care personnel exposed to COVID-19 based on additional filtration performance testing conducted by the National Institute for Occupational Safety and Health (NIOSH) – National Personal Protective Technology Laboratory (NPPTL) of the Centers for Disease Control and Prevention (CDC) (referred to below as the NIOSH testing). As such, the FDA has revised and reissued April 3, 2020, EUA as explained below.
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 the 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.1 The FDA is taking this public health action because a number of these respirators failed to demonstrate a minimum particulate filtration efficiency of 95 percent in testing conducted at NIOSH.
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. For other information, please see FDA’s enforcement policy on face masks, as described in the April 2020 Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)” Guidance.
