| Device |
non-niosh-approved disposable filtering facepiece respirators (ffrs) |
| Definition |
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 |
| Physical State |
A facial mask with an N95 filter. |
| Technical Method |
The user places the strap in place to hold the mask over the nose and mouth. |
| Target Area |
Face. |
| Review Panel |
General Hospital |
|---|
| Product Code | QKU |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices
(DHT4B)
|
|
Not Classified Reason
|
EUA - Emergency Use Authorization
|
|---|
| Submission Type |
EUA - Emergency Use Authorization
|
|---|
| 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
|
|---|
| Third Party Review |
Not Third Party Eligible |
