| Device |
barrier face covering within the scope of the face mask and barrier face covering enforcement policy |
| 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. |
| Physical State |
Solid materials. |
| Technical Method |
Physical barrier to materials. |
| Target Area |
Nose and mouth. |
| Review Panel |
General Hospital |
|---|
| Product Code | QOZ |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control Devices
(DHT4C)
|
|
Not Classified Reason
|
Enforcement Discretion
|
|---|
| Submission Type |
Enforcement Discretion
|
|---|
| Device Class |
Not Classified
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standard
|
| Third Party Review |
Not Third Party Eligible |
