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510(k) Data Aggregation

    K Number
    K213848
    Device Name
    Medical nitrile examination gloves (Model: JL001)
    Manufacturer
    Guangdong Jiali Pharmaceutical Co.,Ltd
    Date Cleared
    2022-03-25

    (105 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K203593
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medical nitrile examination gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

    Device Description

    The subject device is a powder-free nitrile examination glove, provided as a non-sterile and disposable device. The subject device is mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface and has a rolled rim at the cuff edge.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information for the Medical Nitrile Examination Gloves (Model: JL001), based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test MethodTest PurposeAcceptance CriteriaReported Device PerformanceConclusion
    ASTM D6319-19 (Physical Dimensions)To determine the width, length, and thickness of the glovesWidth:
    For S: 80±10 mm
    For M: 95±10 mm
    For L: 110±10 mm
    For XL: 120±10 mm
    Length:
    For S: ≥220mm
    For M/L/XL: ≥230mm
    Finger Thickness: min. 0.05 mm
    Palm Thickness: min. 0.05 mmLot Batch 20210716A:
    Width: S: 7983mm, M: 9397mm, L: 101-105mm, XL: 110mm
    Length: S: 233237mm, M: 233237mm, L: 240244mm, XL: 240244mm
    Thickness: Finger min: 0.12mm, Palm min: 0.08mm
    Lot Batch 20210719A:
    Width: S: 7983mm, M: 9497mm, L: 101-104mm, XL: 110mm
    Length: S: 234236mm, M: 234237mm, L: 240244mm, XL: 240245mm
    Thickness: Finger min: 0.13mm, Palm min: 0.08mm
    Lot Batch 20210721C:
    Width: S: 8085mm, M: 9498mm, L: 105-109mm, XL: 110mm
    Length: S: 230235mm, M: 235238mm, L: 239243mm, XL: 240243mm
    Thickness: Finger min: 0.13mm, Palm min: 0.08mmPassed
    ASTM D6319-19 (Physical Properties)To determine the tensile strength and ultimate elongation before and after acceleration agingBefore Aging:
    Tensile Strength: ≥14Mpa
    Ultimate Elongation: ≥500%
    After Aging:
    Tensile Strength: ≥14Mpa
    Ultimate Elongation: ≥400%For all three lots:
    Before Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥500%
    After Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥400%Passed
    ASTM D6319-19 (ASTM D5151-11) (Freedom from Holes)To determine the holes in the glovesAQL 2.5For all three lots: Pass at AQL 2.5Passed
    ASTM D6319-19 (ASTM D6124-11) (Residual Powder)To determine the residual powder in the gloves
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