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    K Number
    K110944
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    WANGDA PLASTIC CO., LTD
    Date Cleared
    2011-09-01

    (150 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K032908
    Why did this record match?
    Applicant Name (Manufacturer) :

    WANGDA PLASTIC CO., LTD

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

    Powder free vinyl patient examination glove is a non-sterile 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

    The provided text describes the acceptance criteria and performance of a Non-sterile Powder Free Vinyl Patient Examination Gloves, Clear(non-colored) and the study that proves it meets those criteria.

    Acceptance Criteria and Device Performance

    1. A table of acceptance criteria and the 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 D6124-06
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