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510(k) Data Aggregation

    K Number
    K022016
    Device Name
    POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE
    Manufacturer
    TOP GLOVE MEDICAL (THAILAND) CO., LTD.
    Date Cleared
    2002-10-15

    (117 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

    The glove is disposable and intended for Medical purpose that is worn on the hand to prevent contamination between the patient and the examiner.

    Device Description

    Polymer Coated Powderfree Latex Examination Gloves

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding "Polymer Coated Powder Free Latex Examination Gloves." This is a regulatory approval document and does not contain information about acceptance criteria or validation studies in the context of device performance metrics, sample sizes, expert qualifications, or comparative effectiveness studies typically associated with AI/ML-driven device evaluations.

    Therefore, I cannot extract the requested information from the provided text.

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