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U.S. Department of Health and Human Services

Product Classification

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Device decontamination systems for facemasks, surgical masks, face shields, and safety glasses
Definition To decontaminate used facemasks, surgical masks, face shields, and safety glasses
Physical State Solid
Technical Method Decontamination
Target Area PPE
Review Panel General Hospital
Product CodeQLA
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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