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510(k) Data Aggregation

    K Number
    K162923
    Device Name
    NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE
    Manufacturer
    HARTALEGA NGC SDN. BHD.
    Date Cleared
    2017-02-06

    (111 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

    The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Aqua Blue is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
    The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
    The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Dark Blue is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
    The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Dark Violet Blue is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.

    Device Description

    Not Found

    AI/ML Overview

    This document is primarily a 510(k) premarket notification letter from the FDA regarding several types of Nitrile Powder Free Examination Gloves. It focuses on the substantial equivalence determination for these gloves and their indication for use with chemotherapy drugs, detailing the breakthrough times for specific drugs.

    However, the provided text does not contain any information about an AI/ML powered device, acceptance criteria tests related to such a device, sample sizes for test or training sets, ground truth establishment methods, or multi-reader multi-case (MRMC) comparative effectiveness studies.

    The document is solely concerned with the regulatory clearance of medical gloves, which are physical, non-digital medical devices. Therefore, I cannot provide the requested information based on the input text.

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