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
| Device Type ID | 2726 |
| Device Name | N95 Respirator With Antimicrobial/antiviral Agent For Use By The General Public In Public Health Medical Emergencies |
| Physical State | Solid. |
| Technical Method | Filtration. Antimicrobial / Antiviral Agent Effectiveness. |
| Target Area | It Is A Respirator. |
| 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) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.6260 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ORW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2726 |
| Device | N95 Respirator With Antimicrobial/antiviral Agent For Use By The General Public In Public Health Medical Emergencies |
| Product Code | ORW |
| 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 [🔎] |