Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are concentrated in Jiangsu, Shandong and Zhejiang: 4 hold an FDA registration.
What Is It?
For use in healthcare settings by healthcare personnel when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak (see: https://www.fda.gov/media/136403/download) (also see: https://www.fda.gov/media/136664/download). *This excludes NIOSH-approved respirators that are under EUA *This includes authorized KN95s from China under EUA *This excludes KN95s imported under enforcement discretion that don’t have EUA *This includes all authorized non-NIOSH-approved FFRs under EUA
What Is FDA Product Code QKU?
Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs) is FDA product code QKU, not classified.
How Does It Reach the US Market?
This code was created for emergency use authorisation during the COVID-19 public health emergency; sale under it depended on the authorisation, not on a standard premarket submission.