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510(k) Data Aggregation

    K Number
    K081972
    Device Name
    BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES
    Manufacturer
    NITRITEX (M) SDN. BHD.
    Date Cleared
    2008-12-11

    (154 days)

    Product Code
    LZA,LZC
    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 purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with the following Chemotherapy Drugs: Cisplatinum, Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide, 5-Flourouracil, Methotrexate & Paciitaxel.

    Device Description

    BioClean Chemo Emerald Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Sterile)

    AI/ML Overview

    This letter from the FDA pertains to the clearance of a medical device, specifically "BioClean Chemo Emerald Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Sterile)". It is a 510(k) premarket notification, which means the manufacturer demonstrated substantial equivalence to a legally marketed predicate device.

    The document does not provide details about acceptance criteria, a specific study proving the device meets these criteria, or any of the detailed information requested in points 1-9 regarding an AI/algorithm-driven device study.

    This letter is a regulatory clearance for a physical medical glove and does not describe an AI/software device or its performance study.

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

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