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510(k) Data Aggregation

    K Number
    K121591
    Device Name
    FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)
    Manufacturer
    TEKMEDIC (M) SDN BHD
    Date Cleared
    2012-10-11

    (133 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 powder free latex examination glove with vanilla, grape and strawberry flavor 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

    Flavoured, Powder Free And Polymer Coated Latex Examination Glove (Vanilla, Grape and Strawberry) With A Protein Claim Of Less Than 50ug/dm2

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance. The document is a 510(k) premarket notification from the FDA regarding "Flavored, Powder Free and Polymer Coated Latex Examination Glove". It primarily focuses on regulatory approval and substantial equivalence to existing devices, and does not include details on acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of an AI/ML powered medical device.

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