QKU

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

Product code

QKU

Device name

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

Device class

Class N

Medical specialty

Unknown

Marketing pathway

EUA - Emergency Use Authorization

FDA classification 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

Definition text from the FDA device classification database (U.S. federal government work, public domain).