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510(k) Data Aggregation

    K Number
    K141303
    Device Name
    ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
    Manufacturer
    ZHIDA GLOVE CO., LTD.
    Date Cleared
    2014-12-12

    (207 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K120970
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile 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

    Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile 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. Nitrile 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 glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

    AI/ML Overview

    The provided document describes the acceptance criteria and performance of the Nitrile Powder Free Patient Examination Gloves, Blue Color based on non-clinical performance data, as clinical data was not deemed necessary for this device.

    Here's the breakdown of the information requested:

    • 1. A table of acceptance criteria and the reported device performance
    CharacteristicsStandard / Acceptance CriteriaDevice Performance
    DimensionASTM standard D 6319-10 (For Length, Width, Thickness)Meets ASTM standard D 6319-10 (Length: ≥230mm min for all sizes; Width: Small 84-86mm, Medium 94-97mm, Large 105-109mm, X large 114-119mm; Thickness: Finger 0.10mm min, Palm 0.06mm min)
    Physical PropertiesASTM standard D 6319-10 (Before aging/after aging: Elongation ≥500%, Tensile Strength ≥ 14MPa)Meets ASTM standard D 6319-10 (Before aging/after aging: Elongation: 520-580%, Tensile Strength: 22-34 MPa)
    Freedom from pinholes21 CFR 800.20; ASTM D6319-10; ASTM D 5151-06 (Reapproved 2011) (Specifically, for waterleak test on pinhole AQL 2.5 at Inspection Level I)Meets ASTM D 5151-06 (Reapproved 2011) - Holes at Inspection Level I, AQL 2.5
    Powder ResidualASTM standard D 6319-10 and D6124-06 (Reapproved 2011) (
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