LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K092516
    Device Name
    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
    Manufacturer
    ZI BO YUXIANG GLOVES CO., LTD.
    Date Cleared
    2009-10-07

    (51 days)

    Product Code
    LYZ
    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 glove is a 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 5250-06.

    AI/ML Overview

    This is a submission for a patient examination glove, which is a Class I medical device. The information provided is primarily related to non-clinical performance testing against established standards, and therefore, many of the requested categories regarding clinical studies, expert adjudication, and AI performance are not applicable.

    Here's the breakdown of the available information:

    Acceptance Criteria and Device Performance

    CharacteristicsAcceptance Criteria (Standard)Reported Device Performance
    DimensionASTM standard D 5250-06.Meets
    Physical PropertiesASTM standard D 5250-06.Meets
    Freedom from pinholes21 CFR 800.20Meets
    Powder ResidualASTM standard D 5250-06 and D6124-06
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1