Community Containers (Flap and Daisy)

The Community Containers (Flap and Daisy) are portable, single-use, non-sterile polypropylene sharps collectors designed for safe collection, transportation, and disposal of 1 ml and 2 ml hypodermic needles and syringes in healthcare settings, home care environments, and other areas. The rectangular containers feature a hinged closure cap and are approximately 8.7 cm (L) × 4.3 cm (W) × 15.1 cm (H) with a 325 mL nominal volume.

Both the subject device and predicate (ASP HealthCare Fitpack, K060037) are compact, injection-molded containers with integral molded lids, top openings with hinged closures, and configurations featuring a divider flap and daisy top. Both are non-sterile, single-use, made of polypropylene, and demonstrate impact/leak resistance and needle penetration resistance. The subject device dimensions (8.7 × 4.3 × 15.1 cm) are comparable to the predicate (8.1 × 3.8 × 15.3 cm) and both qualify as pocket sharps containers per ISO 23907-1:2019.

ISO 23907-1:2019 Sharps injury protection — Requirements and test methods-Sharps containers Part 1: Single-use sharps containers. Testing included resistance to penetration (minimum 16 N force, average minimum 18 N) and resistance to spillage by toppling with no evidence of leakage.

The Community Containers are substantially equivalent to the predicate device because they share identical classification (Class II, 21 CFR 880.5570), product code (MMK), indications for use, materials, design features, and manufacturing method. Non-clinical performance testing demonstrates the subject device meets or exceeds the predicate's safety and effectiveness standards for puncture resistance and leak containment, with no meaningful differences in technological characteristics or intended use.