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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 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
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