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U.S. Department of Health and Human Services

Product Classification
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Device sealant, microbial
Regulation Description Surgical drape and drape accessories.
Definition Intended to isolate the site of a surgical incision from microbial contamination and indicated to reduce the risk of skin flora contamination of the surgical incision throughout a surgical procedure.
Physical State Applied as a liquid film which dries to a polymerized, flexible film on the treated skin
Technical Method Cyanoacrylate liquid film applied to the intended incision site dries to a flexible barrier film which immobilizes skin flora in the treated area
Target Area Skin surrounding a planned surgical incision
Regulation Medical Specialty General & Plastic Surgery
Review Panel General Hospital
Product CodeNZP
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		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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