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510(k) Data Aggregation

    K Number
    K091661
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    ZHANG JIA GANG HUAYUAN PLASTIC CO. LTD.
    Date Cleared
    2009-07-27

    (48 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K032908
    Predicate For
    N/A
    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) that meets all of the requirements of ASTM standard D 5250-06.

    AI/ML Overview

    This document describes the acceptance criteria and the study that proves the device meets those criteria for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)".

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicsAcceptance Criteria (Standard)Reported Device Performance
    DimensionASTM D 5250-06Meets
    Physical PropertiesASTM D 5250-06Meets
    Freedom from Pinholes21 CFR 800.20Meets
    Powder ResidualASTM D 5250-06 and D6124-06
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