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U.S. Department of Health and Human Services

Product Classification

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Device protective barrier enclosure
Definition A transparent device designed to cover a patient’s head and upper body and incorporates one or more ports through which the HCP’s hands are passed to perform medical procedures, and provides an extra layer of barrier protection in addition to PPE.
Physical State Protective Barrier Enclosure
Technical Method Protective Barrier Enclosure
Target Area Infection Control
Review Panel General Hospital
Product CodeQLD
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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