KUALA LUMPUR: Mah Sing Group Bhd's healthcare business unit Mah Sing Healthcare Sdn Bhd has received the US Food and Drug Administration (FDA) approval to market nitrile examination gloves in the United States.
Mah Sing, in a statement today, said Mah Sing Healthcare received 510(K) clearance from the FDA on December 4, allowing it to market medical-grade examination gloves throughout the US.
Mah Sing's glove division began operations in May 2021, and within the first few months of operation, it was producing non-medical and industrial gloves.
The group said with the 501(K) clearance, a recent medical device licence from Health Canada, and pending the completion of the European Union (EU) Medical Devices Regulation certificate, Mah Sing Healthcare would be able to export medical-grade gloves to a broader range of markets, including major markets such as the US, Canada and Europe.
Gloves' global demand would continue to rise until 2023, it added.
Post-pandemic glove demand will grow at a rate of 15 per cent to 20 per cent per year, compared to eight per cent to 10 per cent per year prior to the pandemic.
"Demand for gloves is expected to remain consistent due to a structural increase in demand, fears of reinfection, increased health awareness, and hygiene compliance requirements for both the healthcare and non-healthcare sectors," Mah Sing said.
According to Mah Sing, the 510(K) clearance was timely because the group planned to commission all 12 production lines by December and had received numerous customer sales inquiries.
These new high-speed glove dipping machines could produce 38,000 gloves per production line per hour, allowing for a maximum annual production capacity of 3.68 billion pieces.
"To improve cost effectiveness, the glove factory is a highly automated plant. It has auto-strip, auto-count, and auto-stack features, as well as auto dosing of solutions, for increased efficiency. Mah Sing also intends to expand into auto boxing in the near future by collaborating with packing automation experts," it said.
Furthermore, Mah Sing said it would implement the enterprise resource planning system as well as the advanced supervisory control and data acquisition system.
Mah Sing shares closed 1.5 sen or 2.11 per cent lower at 69.5 sen as the noon break today, giving it a market value of RM1.7 billion.