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510(k) Data Aggregation

    K Number
    K103196
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    CHANGDA PLASTIC PRODUCT CO., LTD
    Date Cleared
    2011-04-29

    (182 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K032908
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powder free vinyl 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 vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

    Device: Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)
    Manufacturer: CHANGDA PLASTIC PRODUCT CO., LTD
    510(k) Number: K103196

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicsAcceptance Criteria (Standard)Device Performance
    DimensionASTM standard D 5250-06Meets
    Physical PropertiesASTM standard D 5250-06Meets
    Freedom from pinholes21 CFR 800.20Meets
    Powder ResidualASTM standard D 5250-06Meets
    and D6124-06
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