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510(k) Data Aggregation

    K Number
    K024025
    Device Name
    POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR
    Manufacturer
    KOSSAN LATEX INDUSTRIES (M) SDN. BHD.
    Date Cleared
    2002-12-18

    (12 days)

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

    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Powder-free Nitrile Patient Examination Glove, Violet Color.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) premarket notification letter for a patient examination glove, detailing its classification, regulatory requirements, and indications for use. It does not include any performance data, study designs, or details about ground truth establishment.

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