Definition: Used To Reduce The Risk Of Skin Flora Contamination Of The Surgical Wound During A Surgical Procedure.
| Device Type ID | 2844 |
| Device Name | Antimicrobial Drapes |
| Physical State | Device Is Composed Of Transparent, Breathable Fluid Barrier Film Laminated To Acrylic Pressure-sensitive Adhesive That Contains 2% CHG. Drape Is On A Silicone-coated Release Liner. |
| Technical Method | Transparent, Breathable Fluid Barrier Film Laminated To Acrylic Adhesive That Contains 2% W/w Chlorhexidine Gluconate (CHG). Adhesive Drape Is On A Silicone-coated Release Liner. |
| Target Area | Skin/surgical Wound |
| 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) Infection Control Devices Branch (INCB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4370 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PLY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2844 |
| Device | Antimicrobial Drapes |
| Product Code | PLY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Drape And Drape Accessories. |
| CFR Regulation Number | 878.4370 [🔎] |