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Barrier Face Covering Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Public Health Emergency

Page Type
Product Code
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, Surgical Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators 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-respirators-during-coronavirus-disease-covid-19-public-health, provided that the device does not create undue risk by following the recommendations for this device type outlined in the guidance.
Physical State
Solid materials.
Technical Method
Physical barrier to materials.
Target Area
Nose and mouth.
Review Panel
General Hospital
Submission Type
Enforcement Discretion
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code QOZ is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Barrier Face Covering Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Public Health Emergency

Page Type
Product Code
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, Surgical Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators 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-respirators-during-coronavirus-disease-covid-19-public-health, provided that the device does not create undue risk by following the recommendations for this device type outlined in the guidance.
Physical State
Solid materials.
Technical Method
Physical barrier to materials.
Target Area
Nose and mouth.
Review Panel
General Hospital
Submission Type
Enforcement Discretion
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code QOZ is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.