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510(k) Data Aggregation

    K Number
    K092000
    Device Name
    POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
    Date Cleared
    2009-09-18

    (78 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGDONG ZIBO SHANCHUAN MEDICAL INSTRUMENTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
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    K Number
    K021993
    Device Name
    SHANCHUAN SYRINGE
    Date Cleared
    2003-06-03

    (350 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGDONG ZIBO SHANCHUAN MEDICAL INSTRUMENTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SHANCHUAN Piston Syringe is design for medical purposes to inject fluids into or withdraw fluids from the body. The syringe has a graduated barrel, a plunger, a hub and a needle. The SHANCHUAN Insulin Syringe is design for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needle/hub assembly. The needle shield is colored orange. The syringe fluid path is sterile, non-toxic, non-pyrogen and single use, disposable.
    Device Description
    The SHANCHUAN Piston Syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a nozzle for fitting the hub of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body. The Hypodermic Single Lumen Needle is a device intended to inject below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a hub designed syringe or an intravascular administration set. The Insulin Syringe is a piston syringe, typically sterile, single-use with a needle, used for subcutaneous injection of insulin.
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