Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)

The Gongdong Sharps Container (three models: SCR-01Q, SCR-01G, SCR-03G) is a single-use, disposable, non-sterile polypropylene container designed to safely collect and contain hazardous medical sharps such as needles, syringes, and lancets for transport to disposal. The containers are intended for use by qualified healthcare personnel in healthcare facilities and are not designed for patient contact or use in areas with unsupervised patient access.

The devices are injection-molded polypropylene containers with red barrels and translucent lids, available in three sizes (1 quart, 1 gallon, 3 gallon). Key features include hinged or folding-door closures, puncture-resistant and leak-resistant construction, various mounting options (adhesive holders or wall brackets), and needle unwinders and recappers on the smallest model. All three models passed performance testing for stability, handle strength, penetration resistance, and leak-proof integrity.

ISO 23907-1:2019 (sharps container performance), 49 CFR 178.606 and 178.608 (stacking and vibration testing), OSHA 29 CFR 1910.1030 (bloodborne pathogens/leak-proof requirements), and manufacturer's internal SOPs for repeated-use and capacity testing.

The proposed Gongdong devices are substantially equivalent to two Maxcon predicate devices (K222905 and K180984) based on identical indications for use, same product classification (Class II, 21 CFR 880.5570), identical manufacturing method (injection-molded polypropylene), same general design features (hinged/folding closures, single-use), and equivalent performance across all critical safety tests. Although dimensions and weight differ slightly, these differences do not impair the intended function of sharps disposal and storage.