Vystar Corporation and Alatech Healthcare, LLC receives 510(k) clearance from the US Food and Drug Administration (FDA) to market and sell exam gloves manufactured with Vytex Natural Rubber Latex (NRL). In the near future Alatech plans to introduce exam gloves made with Vytex NRL.
Vystar’s Vytex NRL is an environmentally friendly material which contains virtually undetectable levels of the antigenic proteins that can cause an allergic response, while retaining and improving upon the desirable qualities of latex. The exam gloves made with Vytex will carry the protein label claim of less than 50 µg/dm2 or less of total extractable protein per glove.
Vystar’s CEO, William Doyle, said, “Vystar is excited to add exam gloves as the second Vytex NRL product with FDA 510(k) clearance. This is a significant and promising development for the future growth of our company since the glove category is the largest market for natural rubber latex. Because Vytex NRL is a natural, renewable product, Vystar is well positioned as a producer of eco-conscious raw materials for more than 40,000 products that contain natural rubber latex or petroleum-based synthetics.”
Alatech President & CEO Lawrence Povlacs said, “Alatech views its relationship with Vystar as a strategic partnership for introducing a category of revolutionary natural products in the healthcare arena that represents the first line of defense in infection control for caregivers, patients and consumers globally.”