FDA grants clearance of market, sale of new allergy-friendly latex condom

WILMINGTON, Del. Vystar and Alatech Healthcare on Friday announced that the Food and Drug Administration granted 510(k) clearance to market and sell Alatech's Envy condom manufactured with Vytex Natural Rubber Latex.

The Envy condom will be the first consumer medical product available in the U.S. made from Vystar's patented Vytex NRL, which has less than 2 micrograms/dm2, virtually undetectable levels, of the antigenic proteins that can cause an allergic response, while retaining and improving upon all the desirable qualities of latex.

The Envy condom will carry labeling that will reflect the lowest antigenic protein content currently available in a natural rubber latex medical device in the U.S. Natural rubber latex contains more than 200 proteins, similar to other natural plant materials, of which 13 are known allergens. The Vytex NRL process was created to significantly reduce these known proteins. Vystar's business model is to assist all manufacturers in marketing the Vytex component of their products.

Alatech will market and sell the Envy NRL condom to retailers and through other distribution channels, and expects the product to be available to consumers in the coming months.