1 Vytex ® Natural Rubber Latex: An Eco-Friendly Alternative Raw Material

Vytex ® Natural Rubber Latex (NRL), harvested from the Hevea brasiliensis tree, has transformed latex using a patented process for the production of an ultra low antigenic protein natural rubber latex raw material. The science and applied technology behind its creation is multi-faceted and includes the use of insoluble aluminum hydroxide (Al(OH)3), well known for its protein binding characteristics, in a proprietary blend. The colloidal and physical properties of this Al(OH)3 treated latex are presented and compared with standard CL60 lattices. Extensive field, laboratory and end-product manufacturer evaluations have been conducted globally leading to multiple United States Food and Drug Administration (USFDA) 510(k) filings for selected products. Of those submissions, US FDA clearance has been granted for the Envy ™ condom, made with Vytex NRL and manufactured by Alatech Healthcare, Eufaula, Alabama. The condom will be available for retail sale in the fall of 2009. Specific data presented here includes an assessment of total and antigenic protein concentrations at various stages of manufacturing and the attributes of products mad