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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device surgical apparel with material claims
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.
Product CodeQBW
Regulation Number 878.4040
Device Class 2

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