Tegaderm Post-Op Transparent Antimicrobial Dressing

Tegaderm™ Post-Op Transparent Antimicrobial Dressing is a waterproof, sterile, single-use dressing containing 1.2% chlorhexidine gluconate (CHG) gel pad, intended for use by healthcare professionals to cover and protect closed surgical incisions, laparoscopic incisions, and percutaneous devices (such as sutures, staples, or tissue adhesives) in adult patients. The dressing provides a physical barrier against external contamination including fluids, bacteria, mold, and yeast while allowing continual site observation and moisture vapor exchange.

The device combines a transparent adhesive film backing with an integrated transparent CHG gel pad that absorbs exudate. Key characteristics include: waterproof barrier protection, antimicrobial effectiveness against gram-positive and gram-negative bacteria, yeast, and mold; breathability allowing moisture vapor transmission; transparency for site observation; adhesion and liner release functionality; and terminal sterilization via ethylene oxide. A predetermined change control plan includes bodily fluid barrier protection testing per ASTM F1670.

ASTM Method F1670 Synthetic Blood Penetration standard is referenced for future fluid barrier testing under the predetermined change control plan. Applicable standards and guidance documents were used for design and testing, though specific standards for absorption, moisture vapor transmission rate, adhesion, liner release, antimicrobial effectiveness, and transparency testing are listed but not detailed by name.

The subject device demonstrates the same or similar performance to key features of the predicate device (ReliaTect™ Post-Op Dressing, K163529) including identical antimicrobial ingredient (CHG), similar antimicrobial effectiveness (4-log reduction across multiple organisms), shared characteristics (waterproof, transparent, sterile, single-use, adhesive, absorbent), and comparable intended use. Although the subject device includes additional mold testing and bodily fluid barrier protection, these do not raise new questions of safety or effectiveness and support that the device is as safe and effective as the legally marketed predicate.