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510(k) Data Aggregation

    K Number
    K972090
    Device Name
    POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    1997-11-05

    (154 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

    Powder-Free Hypoallergenic Nitrile Examination Glove is a disposable device intended for medical purposes worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Powder-Free Hypoallergenic Nitrile Examination Gloves

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA regarding "Blue Powder-Free Hypoallergenic Nitrile Examination Gloves." It is a regulatory approval letter and does not contain information about acceptance criteria or a study proving the device meets criteria.

    Therefore, I cannot provide the requested information.

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