Definition: Intended To Isolate The Site Of A Surgical Incision From Microbial Contamination And Indicated To Reduce The Risk Of Skin Flora Contamination Of The Surgical Incision Throughout A Surgical Procedure.
| Device Type ID | 2831 |
| Device Name | Sealant, Microbial |
| Physical State | Applied As A Liquid Film Which Dries To A Polymerized, Flexible Film On The Treated Skin |
| Technical Method | Cyanoacrylate Liquid Film Applied To The Intended Incision Site Dries To A Flexible Barrier Film Which Immobilizes Skin Flora In The Treated Area |
| Target Area | Skin Surrounding A Planned Surgical Incision |
| Regulation Description | Surgical Drape And Drape Accessories. |
| 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 | 878.4370 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NZP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2831 |
| Device | Sealant, Microbial |
| Product Code | NZP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Drape And Drape Accessories. |
| CFR Regulation Number | 878.4370 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADHEZION BIOMEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |