Barrier Face Covering Within the Scope of the Face Mask and Barrier Face Covering Enforcement Policy
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Guangdong and Zhejiang: 3 hold an FDA registration.
- Chengde Technology Co., Ltd. Zhejiang
- Foshan Nanhai Plus Medical Co Ltd Guangdong, contract manufacturer
- Guangdong Dexin Sports Industry Co., Ltd. Guangdong, contract manufacturer
What Is This Device?
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.
What Is FDA Product Code QOZ?
Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy is FDA product code QOZ, not classified.
What Does It Take to Sell It in the United States?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.