| Device |
respirator, n95, 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 |
It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids. |
| Physical State |
N 95 NIOSH-certified respirator made of known filtration materials arranged in layers |
| Technical Method |
NIOSH-certified N95 respirator made of known materials |
| Target Area |
Covers the nose and mouth of the wearer |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | NZJ |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control Devices
(DHT4C)
|
| 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
|
|---|
| Guidance Document
|
| Third Party Review |
Not Third Party Eligible |
