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510(k) Data Aggregation

    K Number
    K991981
    Device Name
    NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR
    Manufacturer
    ALLIANCE RUBBER PRODUCTS SDN. BHD.
    Date Cleared
    1999-08-05

    (52 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, POWDER FREE, DARK BLUE COLOR.

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for Nitrile Examination Gloves. It does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth, sample sizes, or expert qualifications for such studies.

    The letter primarily:

    • Confirms that the device is "substantially equivalent" to predicate devices.
    • Outlines regulatory obligations for the manufacturer.
    • Includes an "Indication For Use" statement for the gloves.

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

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