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510(k) Data Aggregation

    K Number
    K102337
    Device Name
    SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE
    Manufacturer
    CURON SCIENTIFIC CO., LTD
    Date Cleared
    2010-11-08

    (82 days)

    Product Code
    LYZ
    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

    Synthetic Vinyl examination glove, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Powder-Free, Synthetic Vinyl Examination Gloves

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder-Free, Synthetic Vinyl Examination Gloves." This document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/software as a medical device (SaMD).

    Instead, it's a regulatory approval document for a Class I medical device (patient examination glove). The "acceptance criteria" discussed in this document refer to regulatory compliance and the demonstration of substantial equivalence to an already legally marketed predicate device, rather than performance metrics from a technical study for a diagnostic or therapeutic device.

    Therefore, I cannot extract the requested information (1-9) as it pertains to AI/SaMD performance studies from this document.

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