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510(k) Data Aggregation

    K Number
    K121464
    Date Cleared
    2012-07-05

    (49 days)

    Product Code
    Regulation Number
    880.6250
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    BLUE POWER FREE NITRILE EXAMINATION GLOVE

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

    The 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 blue nitrile patient examination glove, tested for use with Chemotherapy drugs, that meets all the requirements of ASTM standard D6319, except for sterility requirements.

    AI/ML Overview

    The provided documentation describes the acceptance criteria and performance of the "Blue Powder Free Nitrile Patient Exam Glove," a Class I medical device. This device is a patient examination glove used to prevent contamination between patient and examiner.

    Here's an analysis of the provided information:

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicStandard (Acceptance Criteria)Device Performance
    DimensionASTM D6319Meets
    Physical PropertiesASTM D6319Meets
    Freedom from PinholesASTM D5151 & ASTM D6319Meets
    Powder ResidualASTM D6124 (acceptance criteria typically
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