Mah Sing Healthcare confirms that it has obtained notification from US Federal Drug Administration on the 510(k) Premarket Notification clearances to market Nitrile Examination Gloves from the biggest glove market in the world.
According to the statement released by Mah Sing, the data will be updated on the FDA website in due course, the 510(k) clearances, Mah Sing Healthcare will now be able to market medical grade examination gloves in the US market.
Mah Sing’s glove division commenced operation in May 2021, and in the first few months of operations, they have been producing mainly non-medical and industrial gloves. With these 510(k) clearances, a recent issuance of a Medical Device License 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 United States, Canada, and Europe.
This will be a timely update as the company will complete commissioning all 12 production lines by December and has already received numerous customer sales inquiries. 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 billion pieces of gloves per annum.
The industry is set to grow at 15-20% annually post-pandemic, however, with Omicron the demand for medical gloves have increased again.
