Product Classification

• 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 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.
• Physical State: Face mask.
• Technical Method: Used to cover the face.
• Target Area: Face.
• Review Panel: General Hospital
• Product Code: QMF
• Premarket Review: Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B); Infection Control and Plastic and Reconstructive 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