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QKUNot classified

Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)

Unknown
FDA source (opens on fda.gov)

QKU is the FDA product code for Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs). FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QKU
Device name
Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)
FDA 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
Device class
Not classified
Review panel
Unknown
Submission type
FDA code 8
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code