Device |
antimicrobial drapes |
Regulation Description |
Surgical drape and drape accessories. |
Definition |
Used to reduce the risk of skin flora contamination of the surgical wound during a surgical procedure. |
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 Medical Specialty |
General & Plastic Surgery |
Review Panel |
General Hospital |
Product Code | PLY |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control Devices
(DHT4C)
|
Submission Type |
510(k)
|
Regulation Number |
878.4370
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |