QSO

Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs

产品代码: QSO
器械名称: Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
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 分类定义

Medical gowns that are worn by healthcare personnel to protect both the patient and the wearer from transfer of microorganisms, body fluids, and particulate material. In addition, these gowns have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs.

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）。

FDA 官方分类页： QSO

分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。