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510(k) Data Aggregation

    K Number
    K110621
    Device Name
    SHENGKUN CHEMICAL
    Manufacturer
    ZIBO SHENGKUN CHEMICAL INDUSTRIAL CO., LTD
    Date Cleared
    2011-08-24

    (174 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 :

    SHENGKUN CHEMICAL

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

    Synthetic Vinyl Examination Glove, Powder Free 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

    Synthetic Vinyl Examination Gloves, Powder-Free

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for "Synthetic Vinyl Examination Gloves, Powder-Free". It does not contain information about acceptance criteria or a study proving that a device meets such criteria.

    The letter confirms that the FDA has reviewed the premarket notification for the gloves and determined they are substantially equivalent to predicate devices. It discusses regulatory compliance and general information but does not detail performance criteria or study results.

    Therefore, I cannot provide the requested information based on this document.

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