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510(k) Data Aggregation

    K Number
    K213604
    Device Name
    ELAZ Nitrile Powder Free Examination Glove
    Manufacturer
    Protect Gloves Co., Ltd.
    Date Cleared
    2022-04-03

    (139 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K210898
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ELAZ Nitrile Powder Free Examination Glove is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    ELAZ Nitrile Powder Free Examination Glove is non-sterile, single use only, disposable, powder free examination glove. The glove is made of Acrylonitrile-butadiene rubber. The glove is designed to meets the specification of ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

    AI/ML Overview

    This document describes the performance testing for the ELAZ Nitrile Powder Free Examination Glove, a Class I medical device. The information provided is for a traditional 510(k) submission, confirming substantial equivalence to a predicate device.

    It's important to note that this is a medical glove, not a software or AI-driven diagnostic device. Therefore, many of the typical acceptance criteria and study designs for AI/software-based medical devices (like MRMC studies, expert ground truth adjudication, training/test set provenance for AI, etc.) are not applicable here. The performance evaluation focuses on physical properties, biocompatibility, and compliance with established ASTM and ISO standards for examination gloves.

    Here's a breakdown of the provided information, framed within the context of a medical glove substantial equivalence submission:

    1. Table of Acceptance Criteria and Reported Device Performance

    The full table from the document (page 6-7) is replicated here, summarizing the acceptance criteria and the test results for the ELAZ Nitrile Powder Free Examination Glove.

    Test MethodologyPurposeAcceptance CriteriaResults
    ASTM D6319-19: Physical Dimensions Test (mm)
    Length (mm)S ≥ 220, M ≥ 230, L ≥ 230, XL ≥ 230S ≥ 220, M ≥ 230, L ≥ 230, XL ≥ 230 (All Pass)
    Width (mm)S: 80±10, M: 95±10, L: 110±10, XL: 120±10S: 87-89, M: 99-101, L: 110-113, XL: 112-115 (All Pass)
    Finger Thickness (mm)≥ 0.05S ≥ 0.16, M ≥ 0.15, L ≥ 0.15, XL ≥ 0.13 (All Pass)
    Palm Thickness (mm)≥ 0.05S ≥ 0.11, M ≥ 0.11, L ≥ 0.11, XL ≥ 0.10 (All Pass)
    ASTM D5151-19Testing for Freedom from holesAQL 2.5Gloves pass AQL 2.5
    ASTM D6124-17Determine the powder residue for powder free gloves
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