Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle

The ProfojectTM Disposable Syringe and ProfojectTM Disposable Syringe with Needle are sterile, single-use manual syringes intended for injecting fluids into or withdrawing fluids from the body in medical settings. The syringe barrel is polypropylene with a Luer slip or Luer lock nozzle, available in volumes from 1mL to 60mL. The syringe-with-needle variant includes hypodermic needles in gauges 18G–27G and lengths 15mm–38mm.

The proposed device differs from the predicate in syringe volume options (missing 2mL, 6mL, 12mL, 35mL sizes; adding none), needle gauge (missing 19G, 24G, 30G), and plunger stopper material (polyisoprene rubber vs. silicone rubber in predicate). Both use polypropylene barrels and plungers, silicone oil lubricant, Luer connectors, and are sterilized via ethylene oxide to SAL 10⁻⁶. Both comply with ISO 7886-1, ISO 80369-7, and ISO 7864.

ISO 7886-1:2017 (manual syringes), ISO 7864:2016 (needles), ISO 9626:2016 (needle tubing), ISO 80369-7:2021 (Luer connectors), ISO 6009:2016 (needle color coding), ISO 10993-1:2018 (biocompatibility), ISO 11135:2014 (EO sterilization validation), USP <788> (particulate matter), ASTM F88, F1929, F1886, F1140, F1980 (packaging and shelf-life).

The devices are substantially equivalent because dimensional and volume differences do not affect intended use—physicians select appropriate sizes based on patient needs. Material differences (polyisoprene vs. silicone stopper) are offset by comprehensive biocompatibility testing showing compliance with ISO 10993-1, including additional hemocompatibility tests beyond the predicate. Bench performance testing confirms all devices meet the same consensus standards (ISO 7886-1, ISO 7864, ISO 80369-7). Both are manual, single-use, sterile, Luer-compatible syringes for injection/aspiration in hospitals and clinics.