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510(k) Data Aggregation

    K Number
    K032084
    Device Name
    POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2003-10-29

    (114 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 disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.

    Device Description

    Powder-Free Synthetic Vinyl Examination Gloves, Blue Color

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for Powder-Free Synthetic Vinyl Examination Gloves, Blue Color. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter states that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on the provided information, but the letter itself does not include the details of the performance study or the acceptance criteria used in that study.

    Therefore, I cannot provide the requested information based on the input document.

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