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510(k) Data Aggregation
K Number
K233037Device Name
Sterile Hypodermic Needles for Single Use
Manufacturer
Zhejiang Kindly Medical Device Co., Ltd.
Date Cleared
2023-12-12
(78 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Kindly Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterile Hypodermic Needle for Single Use are intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Device Description
The proposed device, Sterile Hypodermic Needles For Single Use consists of needle tube, needle hub and hard pack(Butt-end lower protective cap and Upper needle protective cap) or protective cap for needle tube is made from stainless steel (SUS 304), the needle hub made of Polypropylene material (abb. PP) and the colour complies with ISO 6009. Sterile Hypodermic Needles for Single Use have two kinds of sterile barrier type, paper-film package type and hard-pack package. Besides the sterile barrier, the materials of middle package and outer package are same. Middle package is made of 350g ivory board and the outer package is made from double-corrugated paper. The conical fitting of Sterile Hypodermic Needles for Single Use is luer can be used with syringes or other medical device which have 6% conical fitting. It is provided as sterile with EO sterilization, and the sterilization assurance level (SAL) is 10-6. Additionally, each component is made from properly tested raw materials.
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