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

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.

Global Registration Data
Multi-Country Intelligence
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
General, Plastic Surgery Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QPC

View Product Code Classification

Class 2

21 CFR 878.4040

View CFR Regulation

General, Plastic Surgery

Device Characteristics

No

No

No

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.