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U.S. Department of Health and Human Services

Product Classification

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Device mask, surgical, eua authorized
Definition Surgical masks for use in healthcare settings by HCP as PPE to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic. Surgical masks that have been designed, evaluated, and validated consistent with the conditions set forth in FDA’s EUA Authorization letter for these devices and that are not excluded from the scope and are not authorized under the EUA.
Physical State Face mask.
Technical Method Used to cover the face.
Target Area Face.
Review Panel General Hospital
Product CodeQMF
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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