Product Classification

• Device: eua faceshields
• Definition: Authorized faceshields intended for use during the declared public health emergency.
• Physical State: n/a
• Technical Method: n/a
• Target Area: n/a
• Review Panel: General Hospital
• Product Code: QPK
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control Devices (DHT4C)
• Not Classified Reason: EUA - Emergency Use Authorization
• 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

Third Party Review

Not Third Party Eligible