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510(k) Data Aggregation

    K Number
    K212600
    Device Name
    Disposable Medical Nitrile Examination Gloves (Non-sterile)
    Manufacturer
    Suqian Linglian Medical Technology Co., Ltd
    Date Cleared
    2021-11-18

    (93 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K203191
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves (Non sterile). The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I) for single use only. The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

    AI/ML Overview

    The provided document is a 510(k) Premarket Notification for Disposable Medical Nitrile Examination Gloves (Non-Sterile). This type of document is for a medical device that does not use AI/ML, and therefore, the requested information regarding AI/ML device performance and related study details is not applicable.

    However, I can extract the acceptance criteria and performance data for this device based on the non-clinical testing summary provided.

    1. Table of Acceptance Criteria and Reported Device Performance

    Test MethodPurposeAcceptance CriteriaReported Device Performance/Result
    ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions TestTo determine the width, length, and thickness of the glovesWidth:
    80mm ±10mm (for small size)
    95mm ±10mm (for medium size)
    110 mm ±10mm (for large size)
    Length:
    220 mm (Minimum) (for small size)
    230 mm (Minimum)(for medium, large size)
    Thickness:
    Finger -0.05 mm (Minimum) (for small, medium, large size)
    Palm -0.05 mm (Minimum)(for small, medium, large size)Width:
    small size: 82 to 89mm
    medium size: 91 to 96mm
    large size: 115 to 116mm
    Length:
    small size: 230mm (minimum)
    medium size: 240mm (minimum)
    large size: 238mm (minimum)
    Thickness:
    Finger:
    small size: 0.12mm (minimum)
    medium size: 0.13mm (minimum)
    large size: 0.12mm (minimum)
    Palm:
    small size: 0.08 mm (minimum)
    medium size: 0.08mm (minimum)
    large size: 0.09 mm (minimum)
    Passed
    ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements TestTo determine the tensile strength and ultimate elongation before and after acceleration agingBefore Acceleration Aging:
    Tensile Strength (MPa): 14 (Minimum)
    Ultimate Elongation (%): 500 (Minimum)
    After Acceleration Aging:
    Tensile Strength (MPa): 14 (Minimum)
    Ultimate Elongation (%): 400 (Minimum)Before Acceleration Aging:
    Tensile Strength (MPa): 20 (Minimum)
    Ultimate Elongation (%): 521 (Minimum)
    After Acceleration Aging:
    Tensile Strength (MPa): 19 (Minimum)
    Ultimate Elongation (%): 505 (Minimum)
    Passed
    ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical GlovesTo determine the holes in the gloves(Mean) AQL 2.5Passed
    ASMT D6319-19 (ASTM D6124-11) Standard Test Method for Residual Powder on Medical GlovesTo determine the residual powder in the gloves
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