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U.S. Department of Health and Human Services

Product Classification

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Device decontamination systems for gloves, gowns, and other apparel excluding masks, respirators, face shields, safety goggles
Definition To decontaminate used gloves, gowns, and other apparel (not including masks/respirators, face shields, or safety glasses)
Physical State Solid
Technical Method Decontamination
Target Area PPE
Review Panel General Hospital
Product CodeQLB
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible