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510(k) Data Aggregation

    K Number
    K042028
    Device Name
    VINYL EXAMINATION GLOVE, POWDER-FREE, NON-STERILE
    Manufacturer
    ZIBO BORUI PLASTIC & RUBBER PRODUCTS CO., LTD.
    Date Cleared
    2004-08-09

    (12 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

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

    Device Description

    Powder Free Vinyl Examination Gloves

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for Powder Free Vinyl Examination Gloves. It primarily addresses the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

    It does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a clinical study report or performance evaluation section.

    Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory compliance rather than detailed technical or clinical performance data.

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