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    K Number
    K022146
    Device Name
    SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE
    Manufacturer
    SYNTEX HEALTHCARE PRODUCTS CO. LTD.
    Date Cleared
    2002-09-03

    (63 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    Powder-Free Polymer-Coated Latex Examination Glove

    AI/ML Overview

    This document is a 510(k) premarket notification letter for a Syntex Powder-Free Polymer-Coated Latex Examination Glove. It is from the FDA to Syntex Healthcare Products Co Ltd. and states that the device is substantially equivalent to legally marketed predicate devices.

    This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval letter based on substantial equivalence, not a performance study report.

    Therefore, I cannot provide the requested table or answer any of the questions about a performance study, sample sizes, ground truth, or expert qualifications based on the provided text.

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