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Surgical Apparel With Material Claims

Surgical Apparel With Material Claims 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
Surgical Apparel With Material Claims
General, Plastic Surgery Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QBW

View Product Code Classification

Class 2

21 CFR 878.4040

View CFR Regulation

General, Plastic Surgery

Device Characteristics

No

No

No

Not Eligible

Definition

Surgical apparel with material claims are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Surgical apparel with material claims contain components that have been constructed, treated, modified, and/or coated with substances that are intended or known to create or enhance a functional element of the device. Examples include fluid repellency, soil retention, or antimicrobial activity.