VIP Gloves Ltd, a nitrile glove manufacturer with operations in Malaysia and listed on the Australian Securities Exchange, can now proceed with marketing activities in the US after meeting the US Food and Drug Administration’s (FDA) procedural requirements related to imports from non-US sources into the country.
The Beranang (Selangor)-based 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.
This followed the receipt in late July 2021 of the provisional FDA 510(k) Medical Product License approval in 2Q 2021 which provides for the potential to ship and market medical examination nitrile gloves into the US.
VIP has also recently registered an application with the Australian Therapeutic Goods Administration (TGA) to market its nitrile gloves in the country. The company said it will 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,” commented VIP Gloves’ group managing director Yang Chin Kar.
“These moves to expand to the US and Australian markets will also provide a platform for VIP to launch our house brands while supporting the take-up of additional production capacity coming onstream from Lines 7 and 8 and the second factory”.
With the US FDA added to its CE EU Examination Certificate, VIP Gloves can now expand its product reach to a broader market encompassing the US and the European countries.
According to the “Global Nitrile Glove Market: Forecast from year 2019 to 2024” report, demand from Europe, US and Japan accounted for 68% of global gloves’ usage. – Aug 15, 2021
