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510(k) Data Aggregation

    K Number
    K170094
    Device Name
    POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED
    Manufacturer
    Viet Glove Corporation
    Date Cleared
    2017-06-23

    (163 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

    Powder Free Latex Examination Glove, Polymer Coated

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a Powder Free Latex Examination Glove, Polymer Coated. This document does not contain information about acceptance criteria or a study proving that an AI/ML-enabled device meets those criteria.

    The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is specific to the evaluation of AI/ML performance in a medical device context. This document, however, pertains to a physical medical device (examination gloves) and its substantial equivalence to a predicate device based on its intended use and general controls.

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

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