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510(k) Data Aggregation

    K Number
    K212840
    Device Name
    Nitrile Gloves (Model: NE01)
    Manufacturer
    BYD Auto Industry Company Limited
    Date Cleared
    2021-12-11

    (95 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K203191
    Why did this record match?
    Reference Devices :

    K203191

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

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

    Device Description

    The proposed devices are powder-free nitrile examination gloves, provided as non-sterile and disposable devices. The proposed devices are mainly made from nitrile and there are four sizes, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is NBR BLUE 7214 (which composed of Phthalocyanine blue (CAS No.147-14-8) and Propylene glycol (CAS No.57-55-6). The examination glove is smooth surface with textured fingertips and a rolled rim atthe cuff edge.

    The examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

    AI/ML Overview

    This document is a 510(k) Pre-Market Notification for "Nitrile Gloves (Model: NE01)". It does not describe an AI medical device. Therefore, many of the requested fields are not applicable.

    Here's the information extracted from the provided text, focusing on the device's acceptance criteria and the studies performed:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test MethodTest PurposeAcceptance CriteriaReported Device PerformanceConclusion
    ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions TestTo determine the width, length, and thickness of the glovesWidth:
    For M: 95 ± 10mm
    For L: 110 ± 10mm
    For XL: 120 ± 10mm
    Length:
    For M: ≥230mm
    For L: ≥230mm
    For XL: ≥230mm
    Thickness:
    Finger: ≥0.05mm
    Palm: ≥0.05mmWidth:
    For M: 93~96mm
    For L: 104-107mm
    For XL: 112~116mm
    Length:
    For M: 236~239mm
    For L: 236~239mm
    For XL: 255~258mm
    Thickness:
    For M: Finger: 0.060.09mm, Palm: 0.060.08mm
    For L: Finger: 0.060.08mm, Palm: 0.060.08mm
    For XL: Finger: 0.080.10mm, Palm: 0.060.09mmPassed
    ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Properties TestTo 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%Before Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥500%
    After Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥400%Passed
    ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical GlovesTo determine the holes in the glovesAQL 2.5Pass at 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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