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    K Number
    K121157
    Device Name
    POWDER-FREE VIVYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
    Manufacturer
    SHIJAZHUANG JIUYUAN PLASTIC CO., LTD
    Date Cleared
    2012-08-02

    (108 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K032908
    Why did this record match?
    Device Name :

    POWDER-FREE VIVYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

    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 a breakdown of the acceptance criteria and study information for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" based on the provided text, structured according to your requested points:

    Acceptance Criteria and Device Performance Study

    The submission details the non-clinical testing performed to demonstrate that the Powder Free Vinyl Patient Examination Gloves meet predefined acceptance criteria and are safe and effective.

    1. Table of Acceptance Criteria and Reported Device Performance

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