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510(k) Data Aggregation

    K Number
    K061724
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE)
    Manufacturer
    SMART GLOVE CORP. SDN BHD
    Date Cleared
    2006-07-25

    (36 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, Grape Scented, Blue and White color

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves, Grape Scented, Blue And White Color". It primarily focuses on the regulatory approval and substantial equivalence determination for this medical device.

    This document does NOT contain information about acceptance criteria, device performance studies, ground truth establishment, sample sizes for training or testing, or expert qualifications for AI/ML device evaluation.

    Therefore, I cannot provide the requested information from the given text. The request is based on the assumption that the document describes an AI/ML medical device, which is not the case here. This document pertains to a physical medical device (gloves) and its regulatory clearance process, not a software algorithm that would have the study components listed in your request.

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