Product code QKU

Device name
Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)
Medical specialty
Unknown
Device class
N
Review panel
HO
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
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
Source
FDA openFDA device classification dataset