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 [🔎] |