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

QKU · Not classified · Unknown

Classification

FDA Product Code
QKU
Device class
Not classified
Regulation
Review panel
HO
Medical specialty
Unknown
Submission type
8
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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

Market data

Cleared 510(k) submissions
0
Registered establishments
4

Source

Authoritative
FDA Device Classification database
Machine
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