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510(k) Data Aggregation

    K Number
    K093263
    Device Name
    STRETCH VINYL EXAMINATION GLOVE, POWDER FREE, YELLOW/WHITE
    Manufacturer
    QINGDAO LANG HUI IMPORT & EXPORT CO., LTD
    Date Cleared
    2010-04-30

    (193 days)

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

    The Stretch Vinyl examination glove, Powder Free, Yellow/White 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, Stretch Vinyl Examination Gloves, Yellow/White

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about the acceptance criteria or a study proving that a device meets those criteria, as such information would typically be found in the 510(k) submission itself or in a separate performance study report, not in the clearance letter.

    Therefore, I cannot provide the requested details based on the provided text.

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