| Device |
n95 respirator with antimicrobial/antiviral agent |
| Regulation Description |
Surgical apparel. |
| Definition |
A single use, disposable, NIOSH-approved respirator intended for occupational use 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 |
The device is an N95 respirator composed of at least 3 layers of filtration material with bands or ties to secure it to the head, a flexible noseband to insure a close fit and an added, specified antimicrobial and/or antiviral agent added to the respirator. |
| Technical Method |
Device uses a combination of tight facial fit and filtration to help reduce exposure to particulate aerosols plus the addition of an antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions |
| Target Area |
The device is worn over the nose and mouth and is intended to protect the respiratory tract from hazardous particulates |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General Hospital |
|---|
| Product Code | ONT |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices
(DHT4B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4040
|
|---|
| 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 |
