QOZ

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

Product code

QOZ

Device name

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

Device class

Class N

Medical specialty

Unknown

Marketing pathway

Enforcement Discretion

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).