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    K Number
    K082598
    Device Name
    POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE
    Manufacturer
    TANGSHAN ZHONGHONG PULIN GROUP CO., LTD.
    Date Cleared
    2009-01-07

    (121 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    k993247
    Why did this record match?
    Device Name :

    POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE

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

    Powder Free Blue Patient Nitrile Examination Gloves 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

    Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6319-05

    AI/ML Overview

    The provided document describes the acceptance criteria and the study conducted for the Nitrile Powder Free Patient Examination Gloves (Blue). This is a medical device subject to regulatory clearance, and the study focuses on non-clinical performance to demonstrate substantial equivalence to a predicate device.

    Here's an analysis of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicsStandard (Acceptance Criteria)Device Performance
    DimensionASTM standard D 6319-05Meets
    Physical PropertiesASTM standard D 6319-05Meets
    Freedom from pinholes21 CFR 800.20Meets
    Powder ResidualASTM standard D 5250-06 and D6124-01
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