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510(k) Data Aggregation

    K Number
    K033496
    Device Name
    MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USE
    Manufacturer
    INDUSTRIAL CLOTHINGS, LTD.
    Date Cleared
    2004-03-09

    (125 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USE

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

    Midas Touch™ Blue Latex Examination Gloves - Powder free for Chemotherapy use, is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner, and for handling and / or preparation of chemotherapeutic drugs.

    Device Description

    Midas Touch™ Blue Latex Examination Gloves - Powder free for chemotherapy use

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA letter regarding a 510(k) premarket notification for Midas Touch Blue Latex Examination Gloves, confirming substantial equivalence to a legally marketed predicate device. It discusses regulatory compliance and marketing permissions. Therefore, I cannot fulfill your request based on the given input.

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