CardiovascularVystar(R) Corporation And Alatech Healthcare, LLC Announce FDA 510(k) Clearance For Exam Gloves Made With Vytex(R) NRL
Vystar Corporation and Alatech Healthcare, LLC announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market and sell the first exam gloves manufactured with Vytex® Natural Rubber Latex (NRL). Alatech plans to introduce exam gloves made with Vytex NRL in the near future.
This marks the second Vytex NRL product to receive 510(k) clearance from the FDA in a new line of all natural infection control offerings. Alatech"s Envy™ Natural Rubber Latex condom made with Vytex NRL received FDA clearance in May and is expected to be available later this year.
Vystar"s patented Vytex NRL is an environmentally friendly material that contains virtually undetectable levels of the antigenic proteins that can cause an allergic response, while retaining and improving upon the desirable qualities of latex. Alatech"s 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."
According to the American Latex Allergy Association, approximately 17 percent of healthcare workers and up to three percent of the general population in the U.S. experience allergies or sensitivities to traditional latex.
More than 55 manufacturing trials are underway worldwide for gloves and other products made with Vytex NRL including medical and non-medical gloves, foam mattresses and pillows, bandages, adhesives and more. The Vystar Professional Support Team™ provides technical and marketing consultants who provide a wide range of expertise to manufacturing partners on compounding, conducting trials, interpreting results and developing standard operating procedures (SOPs) for successful manufacturing conversion and startup.
Vystar Corporation