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 S
| Device Type ID | 2705 |
| Device Name | Respirator, N95, For Use By The General Public In Public Health Medical Emergencies |
| 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 Description | Filtering Facepiece Respirator For Use By The General Public In Public Health Medical Emergencies. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Infection Control Devices Branch (INCB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.6260 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NZJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2705 |
| Device | Respirator, N95, For Use By The General Public In Public Health Medical Emergencies |
| Product Code | NZJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Filtering Facepiece Respirator For Use By The General Public In Public Health Medical Emergencies. |
| CFR Regulation Number | 880.6260 [🔎] |