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U.S. Department of Health and Human Services

Product Classification

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Device n95 respirator with antimicrobial/antiviral agent for use by the general public in public health medical emergencies
Regulation Description Filtering facepiece respirator for use by the general public in public health medical emergencies.
Definition A single use, disposable, niosh-approved n95 respirator intended for use by the general public in public health medical emergencies to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions.
Physical State Solid.
Technical Method Filtration. Antimicrobial / antiviral agent effectiveness.
Target Area It is a respirator.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeORW
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.6260
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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