In a filing with Bursa Malaysia, the company said Mah Sing Healthcare’s MDR classification falls under Class I-Devices that require completion of a technical file and self-declaration of products’ conformity.

The product stipulated in the clearances are nitrile examination powder-free gloves (non-sterile), it said.

“With the recent issuance of the FDA 510K, Health Canada medical device licence, and now the MDR certificate, Mah Sing Healthcare is ready to accelerate the export of medical grade gloves to the US, Canada, EU, and EEA territories,” it said.

Mah Sing said it has completed the commissioning of all 12 production lines and has already received numerous customer sales enquiries.

The new range of 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 billion pieces of gloves per annum, it added.