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510(k) Data Aggregation

    K Number
    K023754
    Device Name
    VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E
    Manufacturer
    ARISTA LATINDO INDUSTRIAL, LTD. P.T.
    Date Cleared
    2003-03-25

    (139 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

    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

    Vinyl Examination Gloves, Powder Free, with Vitamin E

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for "Vinyl Examination Gloves, Powder Free with Vitamin E". It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

    Therefore, this document does not contain information related to software or AI-powered medical devices. As such, I cannot extract the requested information regarding acceptance criteria, study details, ground truth, or sample sizes related to AI device performance.

    The provided text focuses on regulatory approval for examination gloves based on substantial equivalence, not on performance metrics of a diagnostic or therapeutic AI/software device.

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