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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 and Plastic and Reconstructive Surgery Devices (DHT4B)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible