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U.S. Department of Health and Human Services

Product Classification

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Device non-niosh-approved disposable filtering facepiece respirators (ffrs)
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
Physical State A facial mask with an N95 filter.
Technical Method The user places the strap in place to hold the mask over the nose and mouth.
Target Area Face.
Review Panel General Hospital
Product CodeQKU
Premarket Review Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic Surgery Devices (DHT4B)
Not Classified Reason EUA - Emergency Use Authorization
Submission Type EUA - Emergency Use Authorization
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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