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510(k) Data Aggregation

    K Number
    K032549
    Device Name
    MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
    Manufacturer
    MATANG MFG. SDN. BHD.
    Date Cleared
    2003-09-08

    (21 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K990805
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

    Device Description

    Powder-Free Polychloroprene Patient Examination Glove

    AI/ML Overview

    This is a 510(k) premarket notification for "Powder-Free Polychloroprene Patient Examination Gloves" and does not contain information about software with acceptance criteria or a study demonstrating device performance.

    The provided text is a letter from the FDA confirming substantial equivalence of the gloves to a legally marketed predicate device. It discusses regulatory matters such as registration, listing, good manufacturing practice, and labeling, but does not describe any technical performance criteria or a study with results.

    Therefore, I cannot provide the requested information.

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