VIP Gloves gets approval to market products in the US

KUALA LUMPUR, Aug 13  -- VIP Gloves Ltd, an Australian Securities Exchange-listed nitrile glove manufacturer with operations in Malaysia, has obtained the approval to market its products in the United States (US) after meeting the US Food and Drug Administration’s (FDA) procedural requirements related to imports from non-US sources into the country.

In a statement today, group managing director Yang Chin Kar said the company recently received confirmation that all procedural requirements have been met following successful completion of the US agent information registration with the FDA Industry Systems.

He said this followed the receipt in late July 2021 of the provisional FDA 510(k) Medical Product License approval in the second quarter of 2021, which provided for the potential to ship and market medical examination nitrile gloves into the US.

Yang said the company has also recently registered an application with the Australian Therapeutic Goods Administration (TGA) to market its nitrile gloves in the country and would provide an update once accreditation has been received from the TGA.

“The FDA approval allows us to market our products in the highly lucrative US market while the application to the TGA is also part of our efforts to make inroads into new markets and expand the company’s geographical reach,” he said.

He said these moves to expand to the US and Australian markets would also provide a platform for VIP to launch its house brands while supporting the take-up of additional production capacity coming onstream from lines seven and eight and the second factory.

He added that with the US FDA added to the European Conformity European Union (CE EU) Examination Certificate, VIP is now able to expand its product reach to a broader market.

-- BERNAMA