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510(k) Data Aggregation

    K Number
    K172867
    Device Name
    Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange
    Manufacturer
    GMP MEDICARE SDN BHD (F25)
    Date Cleared
    2018-05-10

    (232 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K211310
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    Nitrile Examination Powder Free Glove, Black; Nitrile Powder Free Glove, Orange

    AI/ML Overview

    The provided text is a 510(k) premarket notification decision letter from the FDA for Nitrile Examination Powder Free Gloves. This document does not contain any information related to acceptance criteria, study details, or device performance for an AI/ML powered medical device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the input material does not pertain to such a device or study.

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