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510(k) Data Aggregation
K Number
K213535Device Name
Sterile Safety Hypodermic Needles for Single Use
Manufacturer
Zhejiang Kangkang Medical-Devices CO., Ltd.
Date Cleared
2022-05-13
(189 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Kangkang Medical-Devices CO., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterile Safety Hypodermic Needles 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 minimize risk of accidental needlesticks.
Device Description
The Sterile Safety Hypodermic Needles for Single Use are composed of a hypodermic needle with a needle safety shield attached to the needle hub, which can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. The device is compatible for use with standard luer slip and luer lock syringes. The Sterile Safety Hypodermic Needles for Single Use is for single use only. It is provided sterile. The sterilization method is EO sterilization and the sterilization assurance level is 10-6.
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K Number
K210229Device Name
Sterile Auto-Disable Syringes with/without Needle for Single Use
Manufacturer
Zhejiang Kangkang Medical-Devices CO., Ltd.
Date Cleared
2022-02-15
(383 days)
Product Code
MEG, FMF, FMI
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Kangkang Medical-Devices CO., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.
Device Description
The Sterile Auto-Disable syringes with/without needle for single use is a syringe with or without needle, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The main principle of the syringe is that after the injection is completed, the device automatically locks the plunger to prevent reuse.
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K Number
K210232Device Name
Sterile Hypodermic Needles for Single Use
Manufacturer
Zhejiang Kangkang Medical-Devices CO., Ltd.
Date Cleared
2021-09-23
(238 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Kangkang Medical-Devices CO., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip syringe and injection devices for general purpose fluid injection/aspiration.
Device Description
The Sterile Hypodermic Needles for Single Use is composed of a needle hub, protective cover, needle tube and jointing, connected with a syringe for general purpose fluid injection/aspiration.
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K Number
K210227Device Name
Sterile syringe for single use with/without needle
Manufacturer
Zhejiang Kangkang Medical-Devices CO., Ltd.
Date Cleared
2021-09-10
(225 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Kangkang Medical-Devices CO., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterile syringes for single use with/without needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
Device Description
The Sterile Syringes for Single Use with/without Needle are three-piece, sterile, single use hypodermic syringes with a 6% (Luer) male connector/lock fitting in various sizes. Each syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.
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