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510(k) Data Aggregation

    K Number
    K192111
    Device Name
    Biodegradable Nitrile Examination Powder Free Glove, Green
    Manufacturer
    Top Glove SDN BHD
    Date Cleared
    2020-09-03

    (395 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Biodegradable Nitrile Examination Powder Free Glove, Green

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Biodegradable Nitrile Examination Powder Free Glove, Green is a non-sterile disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Biodegradable Nitrile Examination Powder Free Glove, Green

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Biodegradable Nitrile Examination Powder Free Glove, Green," and it details the regulatory classification, indications for use, and general controls applicable to the device.

    Therefore, I cannot extract the information required to populate the requested table and answer the questions about the study.

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