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510(k) Data Aggregation

    K Number
    K110016
    Device Name
    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
    Manufacturer
    RONGYAO PLASTIC PRODUCE CO., LTD
    Date Cleared
    2011-08-23

    (232 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K051156
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) 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, Colored (Yellow) are disposable devices which made of poly(vinyl chloride) polymer compound, intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between pattent and examiner and they meets all of the requirements of ASTM standard D 5250-06 el .

    AI/ML Overview

    1. Acceptance Criteria and Reported Device Performance

    CharacteristicsAcceptance Criteria (Standard)Device Performance
    DimensionASTM standard D 5250-06e1Meets
    Physical PropertiesASTM standard D 5250-06e1Meets
    Freedom from pinholes21 CFR 800.20Meets
    Powder ResidualASTM standard D 5250-06e1 and D6124-01Meets (
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