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510(k) Data Aggregation

    K Number
    K222906
    Device Name
    Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
    Manufacturer
    Ningbo Maxcon Medical Technology Co., Ltd.
    Date Cleared
    2023-06-16

    (266 days)

    Product Code
    MMK
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ningbo Maxcon Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Maxcon Reusable Sharps Container is intended to be used for the collection and transportation of used medical sharps. The container is intended to be used in hospitals and clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.
    Device Description
    Maxcon Reusable Sharps Container is of injection molded high density polyethylene plastic, and designed for a multiple-use of 250 cycles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. No part of the container is intended to come in contact with patients. The containers are designed to be non-sterile, puncture resistant, leak resistant on the sides and bottom, impact resistant, closable and stable. The recommended fill level is engraved onto the plastic and corresponds to the product identification label's level line. The container body is in the color of red, while the container lid is in the color of black. The products are supplied to waste management companies that are responsible for transporting, decanting, decontaminating, and destroying the containers. The black lid is used to slide across the container top. When in use, move the lid to show an opening with a size depending on the sharps waste to be dropped, and drop sharps waste into the container safely and effectively by gravitational force, allows easy disposal of sharps. After the sharps is deposited, slide the lid closed along the groove to recover the container body for temporary closure. When the content reaching to the fill line, use a 6" cable tie to lock together the lid and container body for final closure. The container is not for use in area with unsupervised patient access.
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    K Number
    K222905
    Device Name
    Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)
    Manufacturer
    Ningbo Maxcon Medical Technology Co., Ltd.
    Date Cleared
    2023-06-01

    (251 days)

    Product Code
    MMK
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ningbo Maxcon Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Maxcon Sharps containers (1 QT Sharps Container, MA1112; 5.4 QT Sharp Container MA1212 ; 5.4 QT Sharps Container MA1213; 7 Liter Sharps Container MA1324) are single-use, disposable, non-sterile containers, intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, and blood needles by qualified personnel in health care facilities in which medical sharps may be used. All device models are not in contact with or available to the patient in normal use, and all device models are not for use in areas with unsupervised patient access.
    Device Description
    Maxcon Sharps Containers are of injection molded polypropylene plastic, and designed for a single-use by qualified personnel in health care facilities and other facilities in which medical sharps may be used. No part of the container is intended to come in contact with patients. The containers are designed to be puncture resistant, leak resistant on the sides and bottom, impact resistant, closable and stable. Large access openings allow for disposal of sharps with one hand use. The plastic used for the sharps containers are of polypropylene , the same as that of the comparable predicate devices. Labels are printed in black text and a black bio-hazard symbol. Labels are adhered to the containers at the time of the manufacture with a fill line warning not to fill above this line. The cover base and the lid (closure) come pre-assembled with the body not attached. Components are nested together to reduce room occupation in storage and shipping. The final on-site assembly is performed in health care facility by snapping the cover to the body. There is no feature to bend, break, or shear needle ,includes blunting and melting of needle in the containers.
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    K Number
    K180983
    Device Name
    Maxcon Two Gallon Chemotherapy Container
    Manufacturer
    Ningbo Maxcon Medical Technology Co., Ltd.
    Date Cleared
    2019-01-03

    (265 days)

    Product Code
    MMK
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ningbo Maxcon Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Maxcon Two Gallon Chemotherapy Container (Model, MC1321) is intended for safe collection and containment of trace chemotherapy waste including needles, syringes, and empty vials. The container is non-sterile, to be single-used in areas with controlled access, such as nurse's stations, pharmacies and chemo treatment rooms, and the target population is for trained health-care professionals.
    Device Description
    Maxcon Two Gallon Chemotherapy Container (Model: MC1321) is of 2 gallon capability, weight about 470gram, size of 275.6mm (length) ×181.5mm (width)× 275mm (height), and the maximum allowable gross mass of the container defined by the company is 2 Kg.There is no feature to bend, break, or shear needle (includes blunting and melting of needle)in the containers. The container is made of base+gasketed cap+screw-on cap. The plastic components are made of injection-moulded of Poly-propylene (PP). The pad and gasket are made of Ethylene Vinyl Acetate (EVA) foam. The closure system is designed, comprising of 4 components: Gasketed lid, Lid gasket pad, Screw-on cap, Cap gasket.
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    K Number
    K180984
    Device Name
    Maxcon Sharps Container
    Manufacturer
    Ningbo Maxcon Medical Technology Co., Ltd.
    Date Cleared
    2019-01-03

    (265 days)

    Product Code
    MMK
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ningbo Maxcon Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Maxcon Sharps containers(2.2QTSharpsContainer,MA1122;2GSharps Container MA1321;2GSharp Container MA1221; 8GSharps Container MA1352) are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal ofhazardous sharps such as hypodermic needles, syringes, lancets and blood needles.The target population is for qualified personnel in health care facilities in which medical sharps may be used. All the containers are intended to be used in areas where is no unsupervised patient access.
    Device Description
    Maxcon Sharps Containers are made of injection molded polypropylene plastic, and designed for a single-use by qualified personnel in health care facilities and other facilities in which medical sharps may be used, the same as that of the comparable predicate devices. Maxcon Sharps Containers are composed of 3 parts (base+lid+closure).No part of the container is intended to come in contact with patients and the sharps objects that will be placed within the containers. The lid and the closure come pre-assembled with the base not attached. Components are nested together to reduce room occupation in storage and shipping. The final on-site assembly is performed in health care facility by snapping the lid to the base. Labels are on a red background with printed in black text and a black bio-hazard symbol. Labels are adhered to the containers at the time of the manufacture with the fill line warning matching the engraved fill line on the container. There is no feature to bend, break, or shear needle ,includes blunting and melting of needle in the containers.
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