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510(k) Data Aggregation

    K Number
    K082597
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
    Manufacturer
    TANGSHAN LINYUAN PLASTIC PRODUCTS CO., LTD
    Date Cleared
    2008-10-24

    (46 days)

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

    TANGSHAN LINYUAN PLASTIC PRODUCTS CO., LTD

    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)" device, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicsAcceptance CriteriaDevice Performance
    DimensionASTM standard D 5250-06Meets
    Physical PropertiesASTM standard D 5250-06Meets
    Freedom from pinholes21 CFR 800.20 (Water leak test on pinhole AQL)Meets
    Powder ResidualASTM standard D 5250-06 and D6124-01 (
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