Mah Sing Healthcare obtains FDA approval to sell nitrile gloves in US

KUALA LUMPUR: Mah Sing Group Bhd’s healthcare unit, Mah Sing Healthcare Sdn Bhd, has received the United States Food and Drug Administration’s (FDA) approval to market nitrile examination gloves in the US.

The company said in a statement yesterday Mah Sing Healthcare received the 510(K) clearance from the FDA on Saturday.

Its glove division began operations in May.

The group said with the 501(K) clearance, the recent medical device licence from Health Canada and pending the completion of the European Union Medical Devices Regulation certificate, Mah Sing Healthcare would be able to export medical-grade gloves to broader markets.

The group said the 510(K) clearance was timely because it planned to commission 12 production lines this month.

The high-speed glove dipping machines could produce 38,000 gloves per 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 added.