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510(k) Data Aggregation

    K Number
    K211753
    Device Name
    Sterile Syringe With Safety Needle
    Manufacturer
    Jiangxi Hongda Medical Equipment Group Ltd.
    Date Cleared
    2021-10-14

    (129 days)

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

    Jiangxi Hongda Medical Equipment Group Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Syringe with Safety Needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
    Device Description
    The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only. It consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or luer lock syringe. The subject device is available in a variety of syringe volumes and needle sizes. The safety sheath is manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
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    K Number
    K210578
    Device Name
    Medical Nitrile Examination Gloves (Power free, Blue)
    Manufacturer
    Jiangxi Hongda Medical Equipment Group Ltd.
    Date Cleared
    2021-07-10

    (134 days)

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

    Jiangxi Hongda Medical Equipment Group Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medical Nitrile Examination Gloves (Powder free, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The proposed device is Powder Free Nitrile Examination Gloves and has different size specification and color. The proposed device is provided in non-sterile. The proposed device is made of Nitrile. The proposed device has different size specification to the predicate device, but all proposed devices are meet the specifications of ASTM D6319.
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    K Number
    K210821
    Device Name
    Medical PVC Examination Gloves
    Manufacturer
    Jiangxi Hongda Medical Equipment Group Ltd.
    Date Cleared
    2021-07-09

    (112 days)

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

    Jiangxi Hongda Medical Equipment Group Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medical PVC Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The proposed device, Medical PVC Examination Gloves are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is not provided as sterilized The proposed device is made of vinyl chloride.
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    K Number
    K163160
    Device Name
    Sterile Single-use Infusion Set
    Manufacturer
    JiangXi HongDa Medical Equipment Group Ltd.
    Date Cleared
    2017-04-20

    (161 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    JiangXi HongDa Medical Equipment Group Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
    Device Description
    The proposed device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the action of gravity. The proposed device is provided with/without injection needle. It is comprised of protective cap of spike, air vent, air filter, drip chamber, fluid filter, flexible tube, injection site, roller clamp, luer lock connector, protector cap of luer lock connector. The devices are provided sterile and single use.
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    K Number
    K163161
    Device Name
    Sterile Single-use Syringe with Needle
    Manufacturer
    JiangXi HongDa Medical Equipment Group Ltd.
    Date Cleared
    2017-03-20

    (130 days)

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

    JiangXi HongDa Medical Equipment Group Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sterile Single-use Syringe with Needle is intent fluids into or withdraw fluids from the body.
    Device Description
    The proposed devices are for single use only, which are comprised of syringes and needles with various specifications. The syringe consists of barrel, plunger, piston, and the needle consists of needle tube, needle hub, needle cap. The proposed devices shall be operated manually, are not intended for use with syringe pumps. All specifications of proposed devices subject to the same design and the difference between each specification is syringe volume and needle size. The proposed devices are available in a variety combination of needle size and syringe volume.
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    K Number
    K163162
    Device Name
    Sterile Hypodermic Safety Syringes for Single Use
    Manufacturer
    JiangXi HongDa Medical Equipment Group Ltd.
    Date Cleared
    2017-03-20

    (130 days)

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

    JiangXi HongDa Medical Equipment Group Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Hypodermic Safety Syringes for Single Use is intended to be used for medical purpose to inject fluids into or withdraw fluids from the body. After injection, the anti-needlestick feature is manually activated to aid in the prevention of accidental needle stick injuries.
    Device Description
    The proposed devices are for single use only, which are comprised of syringes and needles with various specifications. The proposed devices are available in a variety combination of needle sizes and syringe volumes. All specifications of proposed devices subject to the same design. The proposed devices are intended for manual use only.
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