Notion Vtec making progress in nitrile gloves for US, Europe venture
02 Nov 2020
Notion Vtec Bhd has made inroads for its new healthcare business of disposable nitrile examination gloves following its registration with the US Food and Drug Administration (FDA) for polymer patient gloves for the financial year 2021 via its wholly owned subsidiary, Notion Venture Sdn Bhd.
The group said it has obtained a certificate of registration from Registrar Corp that Notion Venture is registered with the FDA.
However, Notion Vtec said it needs a 510(k), a premarket submission to FDA which demonstrates that the device to be marketed is safe and effective, and the submission is underway.
Apart from that it has submitted the necessary documents to apply for the European Conformity (CE) marking certification for the nitrile gloves from the European Union and the group expects approval to be obtained soon.
Notion Vtec pointed out both certifications are necessary for marketing the nitrile gloves in the US and Europe.
Currently, its gloves are supplied by an original equipment manufacturer and it will be building up its ‘Novid’ brand before the group’s glove production starts in the middle of next year.
Furthermore, Notion Vtec is engaging with potential glove buyers on manufacturing lease agreement for some glove lines to be set up.
Under this arrangement, it will dedicate all the output of the lines to glove buyers on a cost plus basis with an upfront leasing charge over a period of 24 months, which will mitigate the risk of the new business venture.
Source: The Sun Daily Posted on : 02 November 2020