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510(k) Data Aggregation

    K Number
    K071170
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL
    Manufacturer
    SMART GLOVE CORP. SDN BHD
    Date Cleared
    2007-09-14

    (140 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL

    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, Magenta and White Color, Coated with AlloGel and Powder free Nitrile Examination Gloves, Magenta And White Color

    AI/ML Overview

    The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for "Powder Free Nitrile Examination Gloves, Magenta and White Color, Coated with AlloGel" and "Powder Free Nitrile Examination Gloves, Magenta And White Color".

    This document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered medical device. It is a regulatory clearance for physical examination gloves, focusing on their substantial equivalence to a predicate device.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance from this document.

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