PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)

The PA3X Detachable Safety Sleeve Syringe is a sterile, single-use manual syringe with an integrated 23-gauge needle and a detachable polypropylene outer sleeve safety mechanism. It is designed to administer injections or extract body fluids, with the safety sleeve manually advanced after use to cover and lock the needle, reducing needlestick injury risk.

The subject device features a detachable outer sleeve safety mechanism (versus the predicate's hinged sheath lock), is available in 3 mL and 5 mL volumes (predicate offers 10 mL), uses Luer Slip connection only (predicate offers both Slip and Lock), includes 23G × 1-inch needle only (predicate ranges 18G–25G), uses ethylene oxide sterilization (predicate uses radiation), and has 3-year shelf life (predicate 5 years).

ISO 7886-1:2017 (syringe performance), ISO 7864:2016 and ISO 9626:2016 (needle performance), ISO 80369-7:2021 (Luer connectors), ISO 23908:2024 (sharps protection), ISO 10993 series (biocompatibility), ISO 11135:2014 (EO sterilization), ASTM F1980 (shelf-life aging), and USP <85>, <151>, <788> (endotoxins, pyrogens, particulates).

The subject device has the same intended use and fundamental design as the TERUMO SurGuard®3 predicate (K113422). All identified differences—safety mechanism design, available configurations, sterilization method, and shelf life—represent subsets or alternative approaches that were evaluated by recognized performance and biocompatibility standards without raising new safety or effectiveness questions.