Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K170754
    Device Name
    3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing
    Date Cleared
    2017-11-21

    (253 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    3M Company, 3M Health Care

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing are 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.
    Device Description
    3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3MTM Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing are similar dressings with one provided as a film dressing and the latter provided as a film dressing with a soft cloth border. Performance data supports both product configurations. 3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3MTM Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing 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. 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing is bordered, notched and reinforced with soft cloth tape and is designed to provide securement around catheters and other devices. In vitro testing (time kill) demonstrates that the 3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing has an antimicrobial effect against a variety of gram-positive bacteria, gramnegative bacteria, yeast and mold in the dressing.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1