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U.S. Department of Health and Human Services

Product Classification
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Device gowns and other apparel
Definition Gowns and other apparel are authorized under the EUA for use by HCPs in healthcare settings in accordance with CDC recommendations to protect both HCPs and patients from the transfer of SARS-CoV-2 in low or minimal risk level situations to prevent the spread of COVID-19.
Physical State Solid material.
Technical Method Physical barrier to materials.
Target Area N/A
Review Panel General Hospital
Product CodeQZT
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
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
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