Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)

The Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) is a single-use blood collection device intended for collecting capillary blood from the heel of newborns, preemies, and toddlers. It features safety protection mechanisms including a blade, spring, and protective housing, and is sterilized by radiation to a sterility assurance level (SAL) of 10⁻⁶ with a 5-year shelf life.

The proposed device is offered in various depth sizes (0.65–1.80 mm) and width sizes (1.50–3.00 mm). The HHZ-IV adds a new self-locking splinter to prevent false triggering compared to HHZ-II/III. Materials are stainless steel and ABS plastic. Manufacturing involves injection molding, assembly, and packaging in cleanrooms with outsourced radiation sterilization. Design and functionality remain essentially unchanged from the predicate.

ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization and intracutaneous reactivity), ISO 10993-11 (acute systemic toxicity and pyrogenicity), ISO 23908 (sharps injury prevention devices), and FDA Guidance for Medical Devices with Sharps Injury Prevention Feature (2005).