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U.S. Department of Health and Human Services

Product Classification

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Device respirator, n95, 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 It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids.
Physical State N 95 NIOSH-certified respirator made of known filtration materials arranged in layers
Technical Method NIOSH-certified N95 respirator made of known materials
Target Area Covers the nose and mouth of the wearer
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeNZJ
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 880.6260
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible