KUALA LUMPUR, Dec 6 — Mah Sing Group Bhd's healthcare business unit, Mah Sing Healthcare Sdn Bhd, is poised to market medical-grade examination gloves in the United States after obtaining premarket notification clearances from the United States (US) Food and Drug Administration (FDA).
The property developer, which diversified into glove manufacturing this year, said the subsidiary had received the US FDA’s notification letter dated Dec 4, 2021, on the 510(k) premarket notification clearances to market nitrile examination gloves.
“This shall be updated on the FDA website in due course,” the company said in a filing with Bursa Malaysia today.
Mah Sing’s glove division began operation in May 2021. In June, the company announced it was ready for export to Europe after getting PC Management System Pvt Ltd’s Conformitè Europëenne (CE) marking certification and TUV Rheinland LGA Products GmbH’s certification for its nitrile and latex examination gloves.
“With these 510(k) clearances, a recent issuance of a medical device licence from Health Canada and pending the completion of EU Medical Device Regulation (MDR) 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,” it said.
Mah Sing said that this month, it was expected to complete commissioning all 12 production lines under the first phase of its glove business.
“These new high-speed glove dipping machines can produce 38,000 pieces of gloves per production line per hour, enabling a maximum production capacity of up to 3.68 million pieces of glover 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.
Mah Sing said it also planned for autoboxing in the near future by collaborating with packing automation specialists.
The company said its management was determined to put in place enhanced manufacturing practices and would adhere strictly to the environment, social and governance (ESG) and other international regulations such as International Labour Organisation Protocols compliance.
“Demand for gloves is expected to remain steady due to structural increase in demand, fears of re-infection, increased health awareness and hygiene compliance requirements for both the healthcare and non-healthcare sectors,” it added. — Bernama