FDA product code QPC

Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

General, Plastic Surgery·Class 2·21 CFR 878.4040
US regulatory classifications
US Product Code (FDA)
QPC
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4040
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A non-sterile, non-isolation gown intended to be worn by healthcare personnel to provide moderate or high barrier protection in non-sterile and non patient isolation situations. Gowns with antimicrobial/antiviral agents or claims are excluded.

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About this record

Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.