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U.S. Department of Health and Human Services

Product Classification

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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 CodePLY
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)
Regulation Number 878.4370
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible