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510(k) Data Aggregation

    K Number
    K984309
    Device Name
    NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDERED
    Manufacturer
    SUMIRUBBER INDUSTRIES (KEDAH) SDN. BHD.
    Date Cleared
    1999-02-12

    (72 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 glove is worn on the hand of the health care and similar personnel to Prevent contamination between the personnel and the patient being treated.

    Device Description

    NBR 4 Mils, Nitrile Examination Glove Non-Sterile, powdered

    AI/ML Overview

    This is a letter from the FDA regarding a 510(k) submission for a medical device (nitrile examination glove). It primarily discusses the device's substantial equivalence to a predicate device and its regulatory classification, allowing it to be marketed. The document does not contain information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert evaluations. It's a regulatory approval letter, not a clinical study report.

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

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