Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)

The Sterile Hypodermic Syringe for Single Use is a medical injection and withdrawal device available in 20ml, 30ml, 50ml, and 60ml sizes. It consists of a polypropylene barrel and piston, a latex-free synthetic rubber gasket, and medical-grade silicone lubricant, with graduated milliliter markings for dose control.

The device features a barrel, plunger, and piston made of polypropylene with polydimethylsiloxane lubricant. It includes Luer Lock (centric cone) and Luer Slip (50ml eccentric cone) connectors manufactured per EN ISO 80369-7:2021. The subject device omits the 10ml size offered in the predicate and has slightly different cone placement specifications, but otherwise maintains identical design, materials, and structural support mechanisms.

ISO 7886-1:2017 and 2018 (syringe performance), ISO 80369-7:2021 (Luer connectors), EN 868-5:2018 (seal strength), EN ISO 11607-2:2020 (sterile barrier), ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization, irritation, intracutaneous reactivity), ISO 10993-11 (pyrogenicity, acute systemic toxicity), ISO 10993-4:2017 (hemocompatibility), and USP 151 (pyrogenicity).

The subject device is substantially equivalent to predicate K213811 because it shares identical indications for use, design components, materials, connector types, prescription-use classification, single-use status, performance standards, biocompatibility, 5-year shelf-life, and sterilization method (ethylene oxide to SAL 10^-6). Minor differences—the omission of a 10ml size and slight cone placement variations—represent reduced product offerings and design conventions consistent with established syringe standards that do not raise new safety or effectiveness questions.