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510(k) Data Aggregation

    K Number
    K050450
    Device Name
    SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES
    Manufacturer
    ZIBO BLUE INTCO PLASTIC & RUBBER PRODUCTS CO., LTD
    Date Cleared
    2005-04-04

    (41 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES

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

    A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

    Device Description

    Patient Vinyl Examination Gloves, Powderfree, Non-Sterile

    AI/ML Overview

    This request cannot be fulfilled as the provided text is a 510(k) clearance letter for patient examination gloves. This type of document declares substantial equivalence to a predicate device and does not contain information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the AI/ML device context described in the request. The letter is a regulatory compliance document for a physical medical device (gloves), not an AI/ML algorithm.

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