3M™ TEGADERM™ Antimicrobial Transparent Dressing

Vendor/Manufacturer: 3M Health Care

Product/Product Line: Tegaderm™ Antimicrobial Transparent Dressing

FDA Classification Product Code: FRO

FDA Classification Product Code Device Name:

Dressing, Wound, Drug

SUBSTANTIALLY EQUIVALENT to the following products:

1. Becton Dickinson ChloraShield™ I.V. Dressing with CHG Antimicrobial

2. Benehold CHG Transparent Film Dressing

Device Description:

3M™ Tegaderm™ Antimicrobial Transparent Dressing is a film dressing that consists of a polyurethane film coated with a transparent chlorhexidine gluconate (CHG) acrylic adhesive. CHG, a broad spectrum antimicrobial/antifungal agent known to inhibit microbial growth has been formulated into the acrylic adhesive.

The transparent film is breathable, allowing oxygen and moisture vapor exchange, yet is impermeable to external contaminants, including fluids (waterproof), bacteria, viruses and yeast. The dressing must remain intact to protect the IV site from external contaminants.

In vitro testing (time kill) demonstrates that the 3M™ Tegaderm™ Antimicrobial Transparent Dressing has an antimicrobial effect against a variety of gram-positive bacteria, gramnegative bacteria, yeast and mold in the dressing.

In vitro testing shows that the film of the dressing provides a barrier to viruses 27 nm in diameter or larger while the dressing remains intact without leakage. These results have not been studied with regard to prevention of viral infection. No clinical study has been conducted regarding the ability of the dressing to prevent viral infections.

Indications for Use:

3M™ Tegaderm™ Antimicrobial Transparent Dressing is intended to be used to cover and protect catheter sites and to secure devices to the skin. Common applications include covering and securing IV catheters, other intravascular catheters and percutaneous devices.