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510(k) Data Aggregation

    K Number
    K210463
    Device Name
    Thermoplastic Elastomer (TPE) Hybrid Examination Glove
    Manufacturer
    Xuzhou Full Sun Medical Products Ltd.
    Date Cleared
    2022-01-23

    (341 days)

    Product Code
    LZA,THE
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K190942
    Predicate For
    K222531
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

    Device Description

    Thermoplastic Elastomer (TPE) Hybrid Examination Glove is a patient examination glove made from polyethylene resin and styrene-ethylene-styrene (SEBS) compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Thermoplastic Elastomer (TPE) Hybrid Examination Glove:

    1. Table of Acceptance Criteria and Reported Device Performance:

    TestTest MethodPurposeAcceptance CriteriaReported Performance
    DimensionASTM D3767Determine the geometrical dimension of glovesLength: 230 mm min.
    Thickness: Palm - 0.05 mm min., Finger - 0.05 mm min.
    Palm Width: Small 104 ± 5 mm, Medium 107 ± 5 mm, Large 115 ± 5 mm, X large 123 ± 5 mmPass
    Freedom from holes (Water leak)21 CFR 800.20. & ASTM D5151-19Detect the holes on the gloves.G-I/AQL 2.5Pass
    Tensile strength (Before aging/After aging)ASTM D412-16 & ASTM D573-04Evaluate the tensile properties of the gloves and the influence of elevated temperature.Before Aging: 14 MPa, min.
    After Aging: 14 MPa, min.Pass
    Elongation (Before aging/After aging)ASTM D412-16 & ASTM D573-04Evaluate the elongation properties of the gloves and the influence of elevated temperature.Before Aging: 500% min.
    After Aging: 400% min.Pass
    Powder ResidualASTM D6124-06Determine the average powder mass found on the gloves
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