PETALING JAYA: Mah Sing Group Bhd’s unit has received the green light by the United States Food and Drug Administration (FDA) to market nitrile examination gloves in the US market.
The property developer, which diversified into glove manufacturing this year, said its healthcare business unit, Mah Sing Healthcare Sdn Bhd, received the 510(K) pre-market notification clearances from the FDA on Dec 4.
“With these 501(K) clearances, a recent issuance of a medical device licence from Health Canada and pending the completion of the European Union (EU) Medical Devices Regulation certificate, Mah Sing Healthcare will be able to export medical-grade gloves to a wider range of markets, including major markets such as the US, Canada and Europe,” the group said in a statement.
“This is indeed timely as Mah Sing will complete commissioning all 12 production lines by December and have received numerous customer sales enquiries,” it added.
Mah Sing noted these new high-speed glove dipping machines could produce 38,000 pieces of gloves per production line per hour, enabling a maximum production capacity of up to 3.68 billion pieces of gloves per annum.
It said Mah Sing Healthcare’s glove factory is a highly automated plant to enhance cost-effectiveness.
It is equipped with auto-strip, auto count and auto stack features as well as auto dosing of solutions for higher efficiency.
The company said it also planned for auto-boxing in the near future by collaborating with packing automation specialists.
“Demand for gloves is expected to remain steady 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.
Citing industry sources, it said the global demand for gloves would continue to rise until 2023.
“Post-pandemic glove demand will expand at a rate of 15% to 20% each year, compared to 8% to 10% per year pre-pandemic,” Mah Sing said.