LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K020318
    Device Name
    SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES
    Manufacturer
    SCIVOLUTIONS, INC
    Date Cleared
    2003-02-03

    (369 days)

    Product Code
    FRO,MXE
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K992817
    Why did this record match?
    Device Name :

    SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Antibacterial Adhesive Bandages are to be applied to the skin for topical application. The bandages help provide an antibacterial barrier for minor cuts and scrapes.

    Device Description

    Antibacterial adhesive bandages are similar to many pre-amendment and already cleared products with benzalkonium chloride. They are provided in various sizes in a box for over the counter purchase. The benzalkonium chloride concentration is 1%.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The documents are FDA 510(k) letters and a 510(k) summary for "SciVolutions Antibacterial Bandages." They primarily discuss regulatory classifications, indications for use, and a comparison to a predicate device.

    The documents do not include:

    • A table of acceptance criteria or reported device performance metrics.
    • Details about a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).
    • Information about training sets.

    Therefore, I cannot fulfill your request based on the provided input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1