The FDA issued an Emergency Use Authorization (EUA) on April 3rd, 2020 allowing the import of filtering face-piece respirators (FFRs) that are manufactured in China and are not NIOSH approved to be a substitute for N95 if those supplies would run out. This was in response to the nationwide shortage of protective material available to combat COVID-19.
Manufacturers who applied for the EUA within the deadline would be listed, after verification by the NPPTL to confirm the claimed filtration rates, in the FDA's Appendix A, which is a list of non-NIOSH respirators authorized by the EUA for emergency use. On October 15th, 2020 the FDA announced that they would no longer be taking applications for EUA or adding to the list.
Our FDA Emergency Authorized KN95 mask is manufactured by Guangzhou Nan Qi Xing Non-Woven Co, Ltd. They applied and are listed on the FDA's Appendix A as an approved importer of filtering face-piece respirators. Please see the test results from the National Personal Protective Technology Laboratory for the white FDA Emergency Authorized KN95 masks here.
Our FDA Registered mask is manufactured by Guangdong Kaidi Garments Co., LTD. They are an FDA Registered Manufacturer of KN95 masks, but they do not have the FDA EUA designation. You can find their information on the FDA Registration Website by using their Registration/FEI number (3017619370).
- Both of our KN95 masks are FDA registered.
- The FDA EU Authorized KN95 mask is listed on the FDA's Appendix A, as that manufacturer was able to submit their application and samples in time to receive the FDA Emergency Authorized designation.
- The FDA Registered Mask is also FDA registered mask. You can find their manufacturer information on the FDA Registration Website by using their Registration/FEI number (3017619370).
Please note that the FDA Emergency Authorized KN95 Masks and Sustainable KN95 masks are not NIOSH approved.