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510(k) Data Aggregation

    K Number
    K990485
    Device Name
    NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR
    Manufacturer
    ALLIANCE RUBBER PRODUCTS SDN. BHD.
    Date Cleared
    1999-04-23

    (66 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 medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

    Device Description

    NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for Nitrile Examination Gloves. It does not contain any information about the acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

    Therefore, I cannot fulfill your request for this specific input. The document is a regulatory approval for a physical medical product (gloves), not an AI-powered diagnostic or predictive tool.

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