HLB Life Science Disposable Syringe Receives FDA Market Approval

HLB Life Science announced on the 2nd that its disposable syringe Sopject has received premarket notification (510k) approval from the U.S. Food and Drug Administration (FDA).

Following approval for veterinary syringes, the company has now obtained marketing authorization for human syringes, and is expected to make a full-scale entry into the U.S. market. They plan to export human syringes to the U.S. through Allison Medical, a U.S. medical device specialist. A partnership with Allison Medical was established early last year, and veterinary syringes have already been supplied in five shipments.

With the export of human syringes now possible, HLB Life Science anticipates that the annual demand for disposable syringes in the U.S. market will increase to approximately 240 million units. Currently, the operation rates of the Cheonan plant and Anseong Plant 2 are being increased to prepare for shipments to the U.S.

Recently, as U.S. exports of Chinese medical devices have slowed, Sopject is also expected to benefit from this. The company explained that inquiries from global medical device companies have surged.

HLB Life Science plans to obtain the Medical Device Single Audit Program (MDSAP) certification within this year. MDSAP is a single audit program for medical devices across five countries: the U.S., Canada, Japan, Australia, and Brazil. Once certified, medical device audits in these five countries are either fully or partially exempted. Obtaining MDSAP certification is expected to significantly expand HLB Life Science’s overseas market base.

Lee Kwang-hee, Vice President of the Medical Device Business Division at HLB Life Science, said, "Thanks to the product approval, we will make a full-scale entry into the U.S. market. In the short term, we aim to turn a profit through exports, and in the mid to long term, we plan to become the number one syringe company in Korea."