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510(k) Data Aggregation

    K Number
    K141279
    Device Name
    WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
    Manufacturer
    WANGHUI GLOVE CO., LTD.
    Date Cleared
    2014-12-03

    (201 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K120970
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Nitrile Powder Free Patient Examination Gloves, Blue Color 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

    Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Nitrile Powder Free Patient Examination Gloves, Blue Color:

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicsAcceptance Criteria (Standard)Reported Device Performance
    DimensionASTM standard D 6319-10Meets
    Physical PropertiesASTM standard D 6319-10Meets
    Freedom from pinholes21 CFR 800.20Meets
    Powder ResidualASTM standard D 6319-10 and D6124-06(Reapproved 2011)Meets (
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