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510(k) Data Aggregation

    K Number
    K023753
    Device Name
    VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E
    Manufacturer
    ARISTA LATINDO INDUSTRIAL LTD. P.T
    Date Cleared
    2003-03-25

    (137 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, Pre-Powdered, with Vitamin E

    AI/ML Overview

    The provided text is a U.S. FDA 510(k) clearance letter for "Vinyl Examination Gloves, Pre-Powdered with Vitamin E." This document is a regulatory approval and does not contain information on acceptance criteria or a study proving the device meets those criteria, as requested in the prompt.

    The 510(k) process primarily evaluates substantial equivalence to a legally marketed predicate device, rather than detailed performance study results against specific criteria in the way a clinical trial or a performance study for a diagnostic AI device would.

    Therefore, I cannot provide the requested information based on the given text.

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