IWP

Radiographic Protective Glove

产品代码

IWP

器械名称

Radiographic Protective Glove

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 892.6500

FDA 专业组

Radiology

上市路径

豁免 510(k)（仍须遵守通用控制与注册列名）

该代码近三年的 510(k)

5 件

FDA 分类定义

A protective radiographic glove is a "personnel protective shield." The gloves are intended to protect the operator, patient, or other person from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. Note: These devices are not patient examination gloves or surgeon's gloves. -

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）。