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510(k) Data Aggregation

    K Number
    K061505
    Device Name
    POWERED NITRILE BLUE EXAMINATION GLOVES
    Manufacturer
    LIWE TRADING
    Date Cleared
    2007-04-09

    (312 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

    A patient examination Powdered Nitrile Blue Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    POWDERED NITRILE BLUE EXAMINATION GLOVE

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a "Powered Nitrile Blue Examination Glove." It does not contain information about the acceptance criteria, study details, or performance of a device in the context of an AI/medical device study.

    The document is purely a regulatory letter stating that the device is substantially equivalent to legally marketed predicate devices and outlines the regulations the manufacturer must comply with.

    Therefore, I cannot extract the requested information from the given text.

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