QKU · Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)
· Class N
Overview
| Product Code | QKU |
|---|---|
| Device Name | Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs) |
| Device Class | Class N |
| Review Panel |
Identification
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 dont have EUA *This includes all authorized non-NIOSH-approved FFRs under EUA
Recent Cleared Devices (0 of 0)
No cleared devices on record.
