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U.S. Department of Health and Human Services

Product Classification

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Device barrier face covering per enforcement policy for face masks and respirators during the covid-19 public health emergency
Definition A barrier face covering is a product worn on the face, specifically covering at least the wearer’s nose and mouth, with the primary purpose of providing source control and to provide a degree of particulate filtration to reduce the amount of inhaled particulate matter. The device is subject to the Enforcement Policy for Face Masks, Surgical Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-respirators-during-coronavirus-disease-covid-19-public-health, provided that the device does not create undue risk by following the recommendations for this device type outlined in the guidance.
Physical State Solid materials.
Technical Method Physical barrier to materials.
Target Area Nose and mouth.
Review Panel General Hospital
Product CodeQOZ
Premarket Review Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic Surgery Devices (DHT4B)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
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
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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