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510(k) Data Aggregation

    K Number
    K102362
    Device Name
    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
    Manufacturer
    JIANGSU HUAYUAN GLOVES CO., LTD.
    Date Cleared
    2010-10-04

    (46 days)

    Product Code
    LYZ,EXA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K032908
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

    AI/ML Overview

    The device under consideration is "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)".

    Here's an analysis of the acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance:

    CharacteristicsStandard / Acceptance CriteriaDevice Performance
    DimensionASTM standard D 5250-06 e1.Meets
    Physical PropertiesASTM standard D 5250-06 e1.Meets
    Freedom from pinholes21 CFR 800.20 (AQL for water leak test)Meets
    Powder ResidualASTM standard D 5250-06 e1 and D6124-06Meets (
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