QMF
- 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.
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。