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510(k) Data Aggregation

    K Number
    K222472
    Device Name
    Lancing System, Sterile Lancet for Single Use, Lancing Device
    Manufacturer
    Shandong Lianfa Medical Plastic Products Co. Ltd.
    Date Cleared
    2022-11-30

    (106 days)

    Product Code
    QRL, QRK
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shandong Lianfa Medical Plastic Products Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "Lancing System" consists of "Sterile Lancet for Single Use" and "Lancing Device" The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The reusable lancing device is to be used with sterile, single-use lancets, and is to be cleaned and disinfected between each use, and then the lancets are to be disposed of. The lancing device is for use only on a single patient in a home setting. This lancing device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting. "Sterile Lancet for Single Use" is a single use device indicated for capillary blood sampling. It can be used in conjunction with "Lancing Device" in home settings, or be used standalone in both home and hospital settings.
    Device Description
    "Lancing System" consists of "Sterile Lancet for Single Use" and "Lancing Device" "Sterile Lancet for Single Use" is a single use, sterile, medical devices designed to be used in collecting the blood sample. The products are intended to be used by professionals in hospital settings or patients at home. "Sterile Lancet for Single Use" is a disposable blood lancet intended for a single use that is comprised of a cap, a single use blade attached to a solid, non-reusable base, and it is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The needle is protected with a cap before use. The steel needle is made of stainless steel SUS304. The needle cap and needle base are made of polyethylene plastic, and are injection molded. The Sterile Lancet for Single Use is sterilized by gamma irradiation. "Sterile Lancet for Single Use" can be used alone in either home or healthcare settings, or be used together with "Lancing Device" in home settings. Based on different design and shape, there are three different types of "Sterile Lancet for Single Use", and also can accommodate different needle gauges. "Lancing Device" is a multiple use, sterile, medical devices designed to be used in collecting the blood sample. The products can be used by patients and lay persons. Thev are not intended for healthcare workers because the device can not be used among different patients. Lancing Device is a multiple use capillary blood lancet intended for use on a single patient. Before each use, a single use lancet is attached to the reusable case, and when launched, is used to puncture the skin to obtain a drop of blood for diagnostic purposes. After use, the single use blade ("Sterile Lancet for Single Use") is disposed of, and the lancing device is cleaned and disinfected, ready for the next use. The lancing device has five adjustable gears (marked 1 to 5) that allow for different puncture depth. Lancing Device is made of a needle base, spring, a launching part, return spring, launch button, a casing, and a cap. The needle is made of SUS304 stainless steel, the spring material is carbon steel, and the other parts are made of plastic components.
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    K Number
    K222376
    Device Name
    Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)
    Manufacturer
    Shandong Lianfa Medical Plastic Products Co. Ltd.
    Date Cleared
    2022-10-03

    (59 days)

    Product Code
    FMK
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shandong Lianfa Medical Plastic Products Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) is a single use device indicated for capillary blood sampling.
    Device Description
    Lianfa Safety Lancet is a single use, sterile, medical devices designed to be used in collecting the blood sample. The products are intended to be used by professionals and home users. They are intended for over the counter use. Lianfa Safety Lancet is a disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The safety lancet is made up of a needle core, spring, a launching part, and a casing. The steel needle is made of SUS304 stainless steel, the spring material is carbon steel, and the other parts are made of plastic components. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable of further use. Based on the shape and design of the device, there are five different models: PA, PA2, APA, NPA, and TPA. Each model is offered with various gauges of needle.
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