27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)

The 27G x 1/2" TW K-Pack Surshield Needle is a hypodermic needle with a passive sharps protection feature that automatically covers the needle immediately and permanently after use. It is designed for subcutaneous and intramuscular injection in combination with pre-filled syringes, and includes a female luer connector hub made of polypropylene to attach to syringe nozzles.

The subject device has a thin-wall (TW) cannula with an increased inner diameter (0.241–0.281 mm) compared to the predicate's regular wall (0.20–0.24 mm inner diameter), while maintaining the same 27G (0.4 mm) outer diameter, 1/2" length, regular bevel, stainless steel tube, polypropylene hub, and passive sharps protection mechanism. All materials, design construction, sterilization method (ethylene oxide to SAL 10⁻⁶), packaging, and 5-year shelf life remain identical.

ISO 7864:2016 (sterile hypodermic needles), ISO 9626:2016 (stainless steel needle tubing), ISO 80369-7:2021 (small bore connectors), ISO 23908:2011 (sharps injury protection), ISO 11607-1:2019 (packaging for sterilized devices), EN ISO 11135:2014 (ethylene oxide sterilization), ISO 10993-1:2020 (biocompatibility), ISO 10993-7 (EO residual limits), USP <788> (particulate matter), USP <71> (sterility), and USP <85>/<161> (bacterial endotoxin limits).

The increased inner diameter of the thin-wall cannula is a design optimization that does not raise new safety or effectiveness questions because both devices share identical indications for use, intended use, materials, sharps protection mechanism, sterilization validation, and biocompatibility profile. Performance verification testing under ISO 7864 and ISO 9626 demonstrates the thin-wall version performs equivalently to the predicate's regular-wall design, and no clinical data are required because the device is a manual hypodermic needle without novel active elements or patient contact differences.