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510(k) Data Aggregation

    K Number
    K071910
    Device Name
    NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)
    Manufacturer
    HARTALEGA SDN BHD
    Date Cleared
    2007-09-06

    (57 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

    The nitrile examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Nitrile Powder Free Examination Gloves (Blue); Nitrile Powder Free Examination Gloves (Pink)

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding "Nitrile Powder Free Examination Gloves (Blue)" and "Nitrile Powder Free Examination Gloves (Pink)". It confirms that the devices are substantially equivalent to legally marketed predicate devices.

    This document does not contain information about the acceptance criteria or a study proving the device meets those criteria, as requested in the prompt.

    The provided text is a regulatory clearance letter, not a scientific study report. It states that the device is substantially equivalent for the indications for use, which are for medical and dental purposes to prevent contamination between patient and examiner. However, it does not detail any specific performance metrics, test methods, or study results.

    Therefore, I cannot provide the requested information based on the provided text.

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