VIP Gloves Limited (VIP), a nitrile glove manufacturer with operations in Malaysia and listed on the Australian Securities Exchange, will now be able to proceed with marketing activities in the U.S. after meeting the U.S. Food and Drug Administration’s (FDA) procedural requirements related to imports from non-U.S. sources into the country.
The Company recently received confirmation that all procedural requirements have been met following successful completion of the U.S. 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 Q2 2021, which provides for the potential to ship and market medical examination nitrile gloves into the U.S.
VIP has also recently registered an application with the Australian Therapeutic Goods Administration (TGA) to market its nitrile gloves in the country and will provide an update once accreditation has been received from the TGA.
Group Managing Director of VIP, Yang Chin Kar, said: “The FDA approval allows us to market our products in the highly lucrative U.S. 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”.
“These moves to expand to the U.S. 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 U.S. FDA added to the CE EU Examination Certificate, VIP can now expand their product reach to a broader market, the U.S. and the European countries. According to a report, “Global Nitrile Glove Market – Forecast from the year 2019 to 2024”, demand from Europe, U.S, and Japan accounted for 68% of global gloves’ usage.
