| Device |
n95 respirator with antimicrobial/antiviral agent for use by the general public in public health medical emergencies |
| Regulation Description |
Filtering facepiece respirator for use by the general public in public health medical emergencies. |
| Definition |
A single use, disposable, NIOSH-approved N95 respirator intended for use by the general public in public health medical emergencies to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions. |
| Physical State |
Solid. |
| Technical Method |
Filtration. Antimicrobial / antiviral agent effectiveness. |
| Target Area |
It is a respirator. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | ORW |
|---|
| Premarket Review |
Infection Control and Plastic and Reconstructive Surgery Devices
(DHT4B)
Infection Control and Plastic and Reconstructive Surgery Devices
(DHT4B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.6260
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
