Mah Sing gets FDA approval to market gloves in the US

PETALING JAYA: Mah Sing Group Bhd has been granted approval to market nitrile examination gloves in the US by the US Food and Drug Administration (FDA).

The group’s healthcare business, Mah Sing Healthcare Sdn Bhd, received the 510(K) premarket notification clearance from the agency on Dec 4.

“With the 501(K) clearance, the 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,” Mah Sing said in a statement.

Mah Sing views the approval as timely, given that it will complete the commissioning of all 12 of its production lines in December and has received numerous customer sales enquiries.

Furthermore, it noted, industry sources believe global demand for gloves will continue to rise until 2023. Post-pandemic glove demand is expected to grow 15-20% each year compared to 8-10% annually during the pre-pandemic period.

The group said its new high-speed glove dipping machines can produce 38,000 pieces of gloves per production line per hour, translating to a maximum production capacity of up to 3.68 billion pieces of gloves per year.

It has plans for auto-boxing in the near future by collaborating with packing automation specialists.

Apart from that, Mah Sing will implement the enterprise resource planning system and advanced supervisory control and data acquisition system.

“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,” it said.