Iconic Worldwide Berhad (Iconic Worldwide), a Bursa Malaysia listed company that is primarily involved in tourism, property development and manufacturing of personal protective equipment (PPE), announced today that its wholly-owned subsidiary Iconic Medicare Sdn Bhd has obtained the 510(k) premarket notification clearance from the US Food and Drug Administration (FDA) to market and sell nitrile examination powder-free gloves.
With the 510(K) clearance received on December 14, 2021, the Group said it will now be able to distribute its medical-grade gloves throughout the United States.
“The FDA clearance is timely as we have just started operations in our new PPE manufacturing facility for gloves and medical face masks here in Batu Kawan, Penang. According to the Malaysian Rubber Glove Manufacturers Association, the global demand for gloves is expected to hit 420 billion pieces next year. Our aim is to manufacture at least 5% of the total global glove demand within five years, targeting export markets such as US & Europe,” said Iconic Worldwide Berhad managing director Dato’ Tan Kean Tet.
Apart from FDA, the Group has also obtained CE and ISO certifications for its nitrile gloves and medical face masks, all of which will enable the Group to export its products worldwide.
“In the third and fourth quarters of the current financial year, we will ship out 500 million pieces of rubber gloves to the United States, Europe, Africa, Middle-East and South-East Asia. This will be in time for us to materialise it in our financial year 2022 accounts,” he added.
In January 2022, Iconic Worldwide also plans to have a grand opening to showcase the manufacturing facility’s modern features and highly automated machinery. The construction of its new RM200 million PPE manufacturing facility for gloves and medical face masks was previously completed on 9 November 2021.
The Group has started running six double former glove dipping lines, and by February 2022, a total of 12 double former glove dipping lines and 20 medical face mask production lines would be installed and commissioned.