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510(k) Data Aggregation

    K Number
    K992557
    Device Name
    QUALATEX POWDERED LATEX EXAMINATION GLOVES
    Manufacturer
    TAN SIN LIAN INDUSTRIES SDN. BHD.
    Date Cleared
    1999-09-14

    (46 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 gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination betwen patient and examiner.

    Device Description

    Powdered patient latex examination gloves

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding "Qualatex Powered Latex Examination Gloves." This document is a regulatory approval for a medical device and does not contain information about the acceptance criteria and study results for an AI/ML powered medical device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The questions you've asked are specific to the evaluation of AI/ML medical devices, which is not what this document addresses.

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