QKR

Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

产品代码

QKR

器械名称

Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

管理类别

第 N 类（Not Classified）

FDA 专业组

Unknown

上市路径

Enforcement Discretion

标记

豁免 GMP（质量体系）

FDA 分类定义

Face mask is intended to be worn by general public or healthcare personnel and excludes air purifying respirators. The mask covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. The device is either subject to the Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public, provided that the device does not create undue risk by following the recommendations for this device type outlined in the guidance, or to the Face Mask Umbrella EUA, available at https://www.fda.gov/media/137121/download

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）。