QKU

Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)

产品代码

QKU

器械名称

Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)

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

For use in healthcare settings by healthcare personnel when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak (see: https://www.fda.gov/media/136403/download) (also see: https://www.fda.gov/media/136664/download). *This excludes NIOSH-approved respirators that are under EUA *This includes authorized KN95s from China under EUA *This excludes KN95s imported under enforcement discretion that don’t have EUA *This includes all authorized non-NIOSH-approved FFRs under 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）。