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510(k) Data Aggregation

    K Number
    K230447
    Device Name
    Sterile Syringe Bulk Tray
    Manufacturer
    Shanghai Kindly Enterprise Development Group Co., Ltd
    Date Cleared
    2023-08-16

    (176 days)

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

    Shanghai Kindly Enterprise Development Group Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sterile syringe bulk tray is sterile, single-use, and bulk packaged syringes for liquid aspiration and injection procedures.
    Device Description
    The sterile syringe bulk tray is designed for manual and single use. It includes multiple syringes and a bulk tray. Each syringe consists of a barrel, plunger stopper (piston). The barrel and plunger are made from polypropylene, while the plunger stopper is made from lsoprene rubber. The device is available in different syringe volumes and offers both Luer slip (1mL) and Luer lock (1, 3, 5, 10, 20, 30, 50, 60mL) connectors. The Luer connector is used to connect the syringe to a hypodermic needle for liquid injection or withdrawal. The medical device is enclosed in a thermal-formed plastic tray that is protected by dialyzing paper. It is sterilized using EO gas to ensure a shelf life of 5 years. The bulk tray packaging of the device is advantageous for performing batch liquid injections or withdrawals. In order to maintain sterility, it is advised to utilize the device within 5 hours after the bulk tray has been opened. This device is specifically designed for application in aseptic environments and should only be handled by medical professionals.
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    K Number
    K223327
    Device Name
    Sterile Aesthetic Cannula and Hypodermic Needle
    Manufacturer
    Shanghai Kindly Enterprise Development Group Co., Ltd
    Date Cleared
    2023-02-16

    (108 days)

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

    Shanghai Kindly Enterprise Development Group Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The product is intended to use for injecting fluids intradermally. It is for adult only (greater than 21 years old).
    Device Description
    The Sterile Aesthetic Cannula and Hypodermic Needle is a combined medical device, including a blunt needle-cannula and a hypodermic needle. The sharp needle consists of a needle hub, a needle, and a protective cap. The blunt needle-cannula consists of a needle hub, a blunt cannula, and a protective cap. The device is provided for single-used, sterilized, and prescription use only. It offers various model configurations, including multiple needle gauge sizes, lengths, and tips, to fit most usage scenarios.
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    K Number
    K223678
    Device Name
    Sterile Syringes for Single Use
    Manufacturer
    Shanghai Kindly Enterprise Development Group Co., Ltd.
    Date Cleared
    2023-02-09

    (63 days)

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

    Shanghai Kindly Enterprise Development Group Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sterile Syringes for Single Use are sterile, single-use, disposal, without needle and manually operated syringes intended to use with a 6% conical fitting device for injection of drug into the body. The syringes are intended for use immediately after filling and are not intended to contain the fluid/medication for extended periods of time.
    Device Description
    KDL Sterile Syringes for Single Use are composed of barrel, plunger, and a moveable piston. The plunger does not contact any part of the fluid path, rather the plunger which attaches to the piston and the barrel are fluid path components. Materials of construction for the components have been shown to meet the applicable requirements of ISO 10993-1. Additionally, there is a small amount of lubricant for moving the plunger smoothly along the inside surface of the barrel. The connector is a universal luer threaded style connector. The device is used in general medicine in clinical, hospital, or other settings of healthcare professionals. The Sterile Syringes for Single Use have different specifications, include 1ml, 3ml, 10ml, 20ml and 30ml.
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    K Number
    K221416
    Device Name
    Sterile Safety Syringes for Single Use
    Manufacturer
    Shanghai Kindly Enterprise Development Group Co., Ltd
    Date Cleared
    2022-08-31

    (107 days)

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

    Shanghai Kindly Enterprise Development Group Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Safety Syringes for Single Use are 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 mimize risk of accidental needle sticks. The Sterile Safety Syringes for Single Use are single use, disposable devices, provided sterile.
    Device Description
    The proposed device consists of a safety hypodermic needle and a luer slip or luer lock syringe. Models of Sterile Safety Syringes for Single Use shown in Table 11.1 and 11.2 are available in various models according to different syringe volume and needle specifications.
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    K Number
    K212972
    Device Name
    KDL Safety Needles
    Manufacturer
    Shanghai Kindly Enterprise Development Group Co., Ltd
    Date Cleared
    2022-08-18

    (335 days)

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

    Shanghai Kindly Enterprise Development Group Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The safety needles are intended to be used with a Luer lock syringe for aspiration and injection 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-stick.
    Device Description
    The KDL Safety Needle is a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath could be manually activated when the needle is withdrawn from the body before disposal, minimizing the risk of needle sharps injury during disposal. It is activated manually by hand or any solid surface. The self-locking mechanism is positioned within the center and the proximal end of the sheath. The hinge structure could let clinical personnel flexibly adjust the sheath to the designed position for use. The KDL Safety Needle has various colors, needle gauge sizes, and needle length sizes, which could be applied in different clinic-use scenarios. Meanwhile, the KDL Safety Needle is sterilized by ethylene oxide and without any pyrogen or latex.
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    K Number
    K220183
    Device Name
    Sterile Safety Syringes for Single Use (Retractable)
    Manufacturer
    Shanghai Kindly Enterprise Development Group Co., Ltd
    Date Cleared
    2022-07-21

    (178 days)

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

    Shanghai Kindly Enterprise Development Group Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Safety Syringe for Single Use (Retractable) is intended to provide a safe and reliable method of injecting fluids into or withdrawing fluids from the body. The Sterile Safety Syringe for Single Use (Retractable) is designed to aid in the prevention of needle stick injuries and reduce the potential for syringe reuse. The Sterile Safety Syringe for Single Use (Retractable) is a single use, disposable device, provided sterile.
    Device Description
    The proposed device, Sterile Safety Syringe for Single Use (Retractable), is available in 1ml. The proposed device consists of seven components:(1) protective cap, (2) needle tube, (3) connecting seat, (4) plunger stopper, (5) sliding sleeve, (6) barrel, (7) plunger. The proposed devices are sterilized by ethylene oxide to achieve a SAL 10-6 and supplied in sterility maintenance small package which could maintain the sterility of the device during the shelf life of 5 years.
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    K Number
    K220185
    Device Name
    Sterile Safety Insulin Syringes for Single Use
    Manufacturer
    Shanghai Kindly Enterprise Development Group Co., Ltd.
    Date Cleared
    2022-07-11

    (168 days)

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

    Shanghai Kindly Enterprise Development Group Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Safety Insulin Syringes For Single Use are a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U40 or U100 insulin into the body, the sliding sleeve helps protect against needle puncture once activated.
    Device Description
    KDL Sterile safety insulin syringes have a sliding sleeve which is designed to shield the injection needle to protect the user from needle puncture and the sliding sleeve helps protect against needle puncture once activated. The sliding sleeve can be activated manually.
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    K Number
    K192179
    Device Name
    Oral/Enteral Syringe
    Manufacturer
    Shanghai Kindly Enterprise Development Group Co., Ltd
    Date Cleared
    2020-05-01

    (263 days)

    Product Code
    PNR
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shanghai Kindly Enterprise Development Group Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for use as a dispenser, a measuring device. It is used to deliver fluids into the body or enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.
    Device Description
    The proposed device is a disposable enteral feeding syringe provided two models, including Type A and Type B, the main difference is the piston of Type A is rubber stopper made of isoprene rubber, and the piston of Type B is rubber pad made of silicone rubber. The proposed device consists of a syringe barrel, syringe plunger and piston (rubber stopper or rubber pad). They are available in 1ml, 3ml, 5ml, 10ml, 20ml, and 60ml. The enteral syringes are sterilized by Ethylene Oxide to achieve a SAL of 10-6 and supplied maintenance package which could maintain the sterility of the device during the shelf life of five years.
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