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510(k) Data Aggregation

    K Number
    K120970
    Device Name
    NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE)
    Manufacturer
    TANGSHAN ZHONGHONG PULIN PLASTIC CO.,LTD
    Date Cleared
    2012-07-19

    (111 days)

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

    K993247

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

    Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) 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 Nitrile Patient Examination Gloves , Blue Color that meets all of the requirements of ASTM standard D 6139-10

    AI/ML Overview

    This document is a 510(k) summary for a medical device called "Powder Free Nitrile Patient Examination Gloves, Blue Color." It aims to demonstrate that this new device is substantially equivalent to a legally marketed predicate device.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicsAcceptance Criteria (Standard)Device Performance
    DimensionASTM standard D 6139-10Meets
    Physical PropertiesASTM standard D 6139-10Meets
    Freedom from pinholes21 CFR 800.20Meets
    Powder ResidualASTM standard D 5250-06 and D6124-06
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