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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeQMF
Device Class Not Classified

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