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510(k) Data Aggregation

    K Number
    K062714
    Device Name
    SYNTHETIC VINYL PATIENT EXAM GLOVES, PRE-POWDERED, YELLOW
    Manufacturer
    BAODING GUANZHONG GLOVE CO., LTD.
    Date Cleared
    2006-12-15

    (95 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 VINYL PATIENT EXAM GLOVES, PRE-POWDERED, YELLOW

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

    A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

    Device Description

    SYNTHETIC VINYL PATIENT EXAM GLOVES PRE-POWDERED, YELLOW

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for "Synthetic Vinyl Patient Examination Gloves Pre-Powdered, Yellow," stating that the device is substantially equivalent to legally marketed predicate devices. It does not include details about device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

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