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510(k) Data Aggregation

    K Number
    K984020
    Device Name
    POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)
    Manufacturer
    KOSSAN LATEX INDUSTRIES (M) SDN. BHD.
    Date Cleared
    1998-12-23

    (41 days)

    Product Code
    LYY
    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 patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Powdered Latex Patient Examination Glove with protein content labeling claim (150 µg/g glove or less)

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter for a powdered latex examination glove, and it does not contain information about acceptance criteria, study details, or performance data for a device as requested in your prompt. The letter only states that the device is substantially equivalent to legally marketed predicate devices.

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