QOZ

Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy

产品代码

QOZ

器械名称

Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy

管理类别

第 N 类（Not Classified）

FDA 专业组

Unknown

上市路径

Enforcement Discretion

FDA 分类定义

A barrier face covering is a product worn on the face, specifically covering at least the wearer’s nose and mouth, with the primary purpose of providing source control and to provide a degree of particulate filtration to reduce the amount of inhaled particulate matter. The device is subject to the Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency, available 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.

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）。