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510(k) Data Aggregation

    K Number
    K110248
    Device Name
    POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR
    Manufacturer
    JIANGSU DONGLING PLASTIC & RUBBER CO., LTD
    Date Cleared
    2011-06-10

    (133 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K082598
    Why did this record match?
    Device Name :

    POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR

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

    Powder Free Nitrile Patient Examination Gloves, White 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

    Powder Free Nitrile Patient Examination Gloves, White Color are made of synthetic rubber, intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device meets all of the requirements of ASTM standard D 6319 00a (2005)e1.

    AI/ML Overview

    The acceptance criteria and study proving the device meets these criteria are described below.

    1. Acceptance Criteria and Device Performance

    The device is "Powder Free Nitrile Patient Examination Gloves, White Color". The acceptance criteria and reported device performance are presented in the table below:

    CharacteristicsAcceptance Criteria (Standard)Reported Device Performance
    DimensionASTM standard D 6319 00a (2005)e1.Meets
    Physical PropertiesASTM standard D 6319 00a (2005)e1.Meets
    Freedom from pinholes21 CFR 800.20Meets
    Powder ResidualASTM standard D 6319 00a (2005)e1. and D6124-06
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