QMF

Mask, Surgical, Eua Authorized

产品代码
QMF
器械名称
Mask, Surgical, Eua Authorized
管理类别
第 N 类(Not Classified)
FDA 专业组
Unknown
上市路径
EUA - Emergency Use Authorization

FDA 分类定义

Surgical masks for use in healthcare settings by HCP as PPE to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the declared public health emergency. Surgical masks that have been designed, evaluated, and validated consistent with the conditions set forth in FDA's EUA Authorization letter for these devices and that are not excluded from the scope and are not authorized under the EUA.

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: QMF
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。