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510(k) Data Aggregation

    K Number
    K130473
    Device Name
    NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
    Manufacturer
    HARTALEGA SDN BHD
    Date Cleared
    2013-07-05

    (133 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 Powder Free Examination Glove is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Nitrile Powder Free Examination Glove (Aqua Blue); Nitrile Powder Free Examination Glove (Aqua Blue)-Extended Cuff; Nitrile Powder Free Examination Glove (Orange); Nitrile Powder Free Examination Glove (Orange)-Extended Cuff; Nitrile Powder Free Examination Glove (Black); Nitrile Powder Free Examination Glove (Black)- Extended Cuff

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA regarding several types of Nitrile Powder Free Examination Gloves. It primarily confirms substantial equivalence to predicate devices and outlines regulatory compliance. It does not contain any information about a study proving device performance against acceptance criteria using retrospective or prospective data, expert ground truth, or an AI algorithm.

    Therefore, I cannot provide the requested details about acceptance criteria or a study based on the provided text. The document focuses on regulatory approval based on equivalence, not on the performance of a device as evaluated in a clinical or analytical study.

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