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510(k) Data Aggregation

    K Number
    K231363
    Device Name
    Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
    Manufacturer
    Hantech Medical Device Co., Ltd.
    Date Cleared
    2023-09-27

    (139 days)

    Product Code
    NGT
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hantech Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hantech Pre-filled 0.9% Normal Saline Flush Syringes, are in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the manufacturer for the appropriate device.
    Device Description
    The Hantech Pre-filled 0.9% Normal Saline Flush Syringes is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap. The device will be marketed as 10mL syringe with a 3mL, 5mL or10mL fill volume according to the market needs. It is terminally sterilized by steam sterilization. The product has a shelf life of 1 years.
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    K Number
    K222739
    Device Name
    Disposable Insulin Pen Needle
    Manufacturer
    Hantech Medical Device Co., Ltd.
    Date Cleared
    2023-04-06

    (209 days)

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

    Hantech Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. It is sterile and for single use only. It can be used by the patient at home or healthcare professionals at medical/health care centers.
    Device Description
    The Disposable Insulin Pen Needle consists of a needle tube, a needle hub, a needle container, a needle shield and a seal. The needle tube is a double-ended needle that can be assembled into the needle hub using UV glue. The needle hub has the means of needle assembly attachment to allow it to be screwed onto the pen-injector device. This allows the Non-Patient (NP) end of the needle to penetrate through the rubber septum of the pen injector cartridge. The Patient and NP ends of the needle are lubricated using silicon oil for ease of injection and rubber septum penetration. The needle shield is assembled over the Patient end of the needle to protect the point from damage and accidental needle sticks. This needle assembly is inserted into a needle container and sealed with a peel-away label to provide a sterile barrier and tamper evidence. The peelaway label is pre-printed with information, which includes the lot number and needle gauge / length. It is supplied with several models. Different models are distinguished by needle gauge and length. The Disposable Insulin Pen Needle is a single-use disposable device and is provided sterile (EO sterilization). It is non-toxic and nonpyrogenic.
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    K Number
    K222672
    Device Name
    Disposable Insulin Syringe
    Manufacturer
    Hantech Medical Device Co., Ltd.
    Date Cleared
    2023-03-06

    (181 days)

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

    Hantech Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The product is intended for subcutaneous injection of U-40 insulin in the treatment of diabetes. The product is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.
    Device Description
    The Disposable Insulin Syringe is designed for subcutaneous injection of a desired dose of U-100 and U-40 insulin and has capacity of 0.3mL, 0.5mL, and 1.0mL. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a needle, barrel, needle cap, plunger, piston, and plunger cap(only type A). The needle is a single ended lubricated stainless-steel cannula. The needle is covered by a polypropylene needle cap which is placed on the barrel. The barrel is molded from polypropylene with the exterior permanently marked with the proper scale markings. The piston is attached to the plunger and a Polypropylene plunger cap is placed over the plunger rod(only type A). All products are EO sterilized. The subject device operates on the principle of a piston syringe and has a shelf life of 5 years.
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    K Number
    K221038
    Device Name
    Disposable Medical Masks
    Manufacturer
    Hantech Medical Device Co., Ltd.
    Date Cleared
    2022-09-01

    (147 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hantech Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are in infection control practices to reduce the potential exposure to blood and body fluids.
    Device Description
    The Disposable Medical Masks are single use, three-layer, flat-folded masks with ear loops and nose clamp. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven fabric, and the middle layer is made of melt blown Fabric. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made of Polyamide & Spandex. The nose clamp in the layers of face mask is to allow the user to fit the face mask around their nose, which is made of galvanized iron wire wrapped with PE material. The Disposable Medical Masks will be provided in white, blue, and purple which are sold non- sterile and are intended to be single use, disposable devices.
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    K Number
    K220603
    Device Name
    Disposable Medical Safety Hypodermic Needle
    Manufacturer
    Hantech Medical Device Co., Ltd.
    Date Cleared
    2022-08-23

    (174 days)

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

    Hantech Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Medical Safety Hypodermic Needle is intended for use in the aspiration and injection of fluids for medical purposes. The Disposable Medical Safety Hypodermic Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, 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-stick.
    Device Description
    The Disposable Medical Safety Hypodermic Needle is composed of a needle hub, a needle tube, a needle cap and a sharp injury protection feature. The sharp injury protection feature is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The sharp injury protection feature is activated with one-hand operation by pressing the sharp injury protection feature either with the finger or thumb, or by surface activation. The locking mechanism is positioned within the center and proximal end of the sharp injury protection feature. The hinge feature(sharp injury protection feature) allows the medical practitioner the flexibility to adjust the sharp injury protection feature to its desired position for use.
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