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510(k) Data Aggregation

    K Number
    K091965
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED
    Manufacturer
    PLATINUM GLOVE INDUSTRIES SDN.BHD.
    Date Cleared
    2009-11-24

    (146 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

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

    Device Description

    Powder Free Nitrile Examination Gloves, Black Powder Free Nitrile Examination Gloves, Blue, Grape Scented

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves." It does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

    The letter is a standard FDA communication confirming that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It outlines regulatory requirements that the manufacturer must adhere to.

    Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set size, or ground truth establishment for the training set) from the provided text. This information would typically be found in a separate study report or regulatory submission document describing the performance testing.

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