# Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)
> **Product code: 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
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QKU)
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