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The Tegaderm™ Post-Op Transparent Antimicrobial Dressing is a waterproof, single use, sterile dressing with Chlorhexidine Gluconate (CHG), intended to be used on adult patients by healthcare professionals to cover and protect closed surgical incisions or laparoscopic incision and a percutaneous device(s) (e.g., sutures, staples, tissue adhesives).

Tegaderm™ Post-Op Transparent Antimicrobial Dressing includes a transparent adhesive dressing and an integrated transparent gel pad containing Chlorhexidine Gluconate (CHG) at a concentration of 1.2% (w/w). The transparent adhesive dressing provides a barrier against external contamination including fluids (waterproof), bacteria, mold and yeast, and is classified as a breached skin contact device intended for use on closed incisions.

In vitro testing (log reduction and barrier testing) demonstrates that the CHG gel pad in the Tegaderm™ Post-Op Transparent Antimicrobial Dressing has an antimicrobial effect against, gram-positive and gram-negative bacteria, yeast, and mold in the dressing. The gel pad absorbs fluid. Tegaderm™ Post-Op Transparent Antimicrobial Dressing is transparent, allowing for continual site observation, and is breathable, allowing moisture vapor exchange.

The device is sterile. Terminal sterilization is conducted with ethylene oxide.

As part of the Predetermined Change Control Plan, the Tegaderm™ Post-Op Transparent Antimicrobial Dressing design will be updated to include bodily fluid barrier protection. This product requirement will be tested per the ASTM Method F1670 Synthetic Blood Penetration standard.

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