Mask, Surgical, Eua Authorized
Mask, Surgical, Eua Authorized is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.
US Regulatory Classifications
Device Characteristics
No
No
No
Not Eligible
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 declared public health emergency. 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.
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