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510(k) Data Aggregation

    K Number
    K213371
    Device Name
    Disposable Medical Nitrile Examination Gloves (Model:XYS-001)
    Manufacturer
    Anhui Xinyisheng Medical Technology Co.,Ltd
    Date Cleared
    2021-12-09

    (58 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K192333
    Why did this record match?
    Device Name :

    Disposable Medical Nitrile Examination Gloves (Model:XYS-001)

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

    The Disposable Medical Nitrile Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Disposable Medical Nitrile Examination Gloves (Model: XYS-001, Size Large) is a patient examination qlove and it is made from nitrile compound. It is a single-use, powder-free and nonsterile product. The glove is worn on the examiner's hand to prevent contamination between patient and examiner, and this device meets all the requirement specifications in the ASTM D6319-19 Standard.

    AI/ML Overview

    The provided text describes the 510(k) clearance for "Disposable Medical Nitrile Examination Gloves (Model: XYS-001)". This is a Class I medical device (non-powdered patient examination glove), and the submission focuses on demonstrating substantial equivalence to a predicate device.

    The "study" described is a series of non-clinical bench tests and biocompatibility tests conducted to meet specific performance standards and criteria. There is no multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance study, or training set information as this is not an AI/software device.

    Here's the breakdown of the requested information based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test ItemStandard/Test MethodAcceptance CriteriaReported Device PerformanceConclusion (from document)
    Freedom from HolesASTM D5151Any glove that shows a droplet, stream, or other type of water leakage shall be considered to have failed the test.Did not show a droplet, stream, or other type of water leakagePass
    Physical Dimension TestASTM D412, D3767L size:
    Width: 95±10mm
    Length: 230mm min
    Thickness:
    Finger 0.05mm min
    Palm 0.05mm minL size:
    Width: 110mm
    Length: 237mm
    Thickness:
    Finger 0.142mm
    Palm 0.082mmPass
    Physical Requirement Test (Before Aging)ASTM D412, D573Tensile Strength: 14 Mpa, min.
    Elongation: 500% min.Tensile Strength: 19.1 Mpa
    Elongation: 508%Pass
    Physical Requirement Test (After Aging)ASTM D412, D573Tensile Strength: 14 Mpa, min.
    Elongation: 400% min.Tensile Strength: 25.4 Mpa
    Elongation: 517%Pass
    Powder Free GlovesASTM D6124Max. 2.0mgAverage: 0.5mg (for 5 pcs)Pass
    In Vitro CytotoxicityISO 10993-5:2009If viability is reduced to
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