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 Whi
| Device Type ID | 2837 |
| Device Name | N95 Respirator With Antimicrobial/antiviral Agent |
| 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 Resp |
| 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 Description | Surgical Apparel. |
| Regulation Medical Specialty | General & Plastic Surgery |
| 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 | 878.4040 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ONT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2837 |
| Device | N95 Respirator With Antimicrobial/antiviral Agent |
| Product Code | ONT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Apparel. |
| CFR Regulation Number | 878.4040 [🔎] |