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510(k) Data Aggregation

    K Number
    K131826
    Date Cleared
    2013-11-22

    (155 days)

    Product Code
    Regulation Number
    880.6250
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 (Reapproved 2011).

    Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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

    PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM DS250-06(Reapproved 2011) and ASTM D5151-06(Reapproved 2011) requirements.

    AI/ML Overview

    The provided text describes the acceptance criteria and performance of Powder Free Vinyl Patient Examination Gloves.

    Here's the breakdown of the information requested:

    1. A table of acceptance criteria and the reported device performance

    CharacteristicsAcceptance Criteria (Standard)Device Performance
    DimensionASTM standard D 5250-06 (Reapproved 2011)Meets
    Physical PropertiesASTM standard D 5250-06 (Reapproved 2011)Meets
    Freedom from Pinholes21 CFR 800.20Meets
    Powder ResidualASTM standard D 5250-06 (Reapproved 2011) and D6124-06 (Reapproved 2011)Meets (
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