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510(k) Data Aggregation

    K Number
    K040176
    Device Name
    MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES
    Manufacturer
    MAXTER GLOVE MANUFACTURING SDN BHD
    Date Cleared
    2004-02-24

    (29 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 :

    MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES

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

    A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device (Maxter Powder Free Nitrile Medical Examination Gloves). It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

    This type of document is a regulatory approval, confirming that the device is "substantially equivalent" to a legally marketed predicate device. It typically doesn't detail the specific testing methodologies or results that would be found in a study report.

    Therefore, I cannot provide the requested information based on the given text.

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