Definition: A Single Use, Disposable Surgical Mask For Occupational Use To Cover The Nose And Mouth Of The Wearer To Protect From The Transfer Of Microorganisms,body Fluids And Particulates And Has An Added Antimicrobial And/or Antiviral Agent Which Kills Specif
| Device Type ID | 2840 |
| Device Name | Surgical Mask With Antimicrobial/antiviral Agent |
| Physical State | The Device Is A Surgical Mask Composed Of At Least 3 Layers Of Filtration Material With Bands Or Ties To Secure It To The Head, A Flexible Noseband And An Added, Specified Antimicrobial And/or Antiviral Agent Added To The Surgical Mask |
| Technical Method | Device Uses A Combination Multiple Filtration Layers To Protect From The Transfer Of Microorganisms, Body Fluids And Particulates Plus The Addition Of An Antimicrobial And/or Antiviral Agent Which Kills Specified Pathogensunder Specified Contact Cond |
| Target Area | The Device Is Worn Over The Nose And Mouth And Is Intended To Protect The Respiratory Tract From Transfer Of Microorganisms, Body Fluids And 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) Infection Control Devices Branch (INCB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4040 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OUK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2840 |
| Device | Surgical Mask With Antimicrobial/antiviral Agent |
| Product Code | OUK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Apparel. |
| CFR Regulation Number | 878.4040 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NBC MESHTEC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |