QBW

Surgical Apparel With Material Claims

产品代码

QBW

器械名称

Surgical Apparel With Material Claims

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 878.4040

FDA 专业组

General, Plastic Surgery

上市路径

需提交 510(k) 上市前通告

FDA 历史累计 510(k)

1 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

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.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。