OPH

Radiation Attenuating Medical Glove

产品代码

OPH

器械名称

Radiation Attenuating Medical Glove

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 880.6250

FDA 专业组

General Hospital

上市路径

需提交 510(k) 上市前通告

标记

可走第三方审查

FDA 分类定义

Radiations attenuating medical gloves are medical gloves that are used during medical or surgical procedures involving radiation to shield the hands of the wearer from scattered radiation exposure. The gloves offer some degree of protection to the hand from radiation exposure as well as protection from transmission of infectious agents. The use of these gloves includes procedures that require the use of fluoroscopy or radiography. In addition to meeting the requirements for examination or surgeon¿s gloves, manufacturers should have technical data to show that their attenuation claims meet the energy range of x-rays normally used in medical procedures.

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）。