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510(k) Data Aggregation

    K Number
    K120797
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
    Manufacturer
    SHANDONG SHOUGUANG KINGLIYUAN MEDICAL APPARATUS &
    Date Cleared
    2012-07-27

    (134 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K032908
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANDONG SHOUGUANG KINGLIYUAN MEDICAL APPARATUS &

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

    Powder free vinyl patient 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 Vinyl Patient Examination Gloves, Clear (non-colored)

    AI/ML Overview

    The provided text describes the acceptance criteria and study for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)".

    Here's a breakdown of the requested information:

    1. Table of acceptance criteria and the reported device performance:

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