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U.S. Department of Health and Human Services

Product Classification
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Device drape, surgical, antimicrobial
Regulation Description Surgical drape and drape accessories.
Definition Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.
Physical State Device is a fluid barrier film containing an antimicrobial agent
Technical Method To serve as a physical barrier during a surgical procedure to protect from transfer of microorganisms, body fluids, and particulate material. The added antimicrobial agent is intended to reduce the risk of microbial contamination of the surgical site.
Target Area Surgical wound and skin
Regulation Medical Specialty General & Plastic Surgery
Review Panel General Hospital
Product CodeKKX
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
Recognized Consensus Standards
Guidance Document
Third Party Review
Accredited Persons
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