Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)
Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) are not-classified devices intended for use by healthcare personnel in healthcare settings to prevent wearer exposure to pathogenic biological airborne particulates during N95 respirator shortages resulting from the COVID-19 outbreak, authorized under Emergency Use Authorization including authorized KN95 respirators from China. The product code is QKU, reviewed by the General Hospital panel, with no regulation number assigned. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QKU
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- HO
- Submission Type
- 8
Device Characteristics
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 dont have EUA *This includes all authorized non-NIOSH-approved FFRs under EUA
Unclassified Reason
11
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.