Up to 17% of healthcare workers and 1% of the general population are allergic to latex, according to the American Latex Allergy Association (ALAA). Latex allergies develop over time from continual contact with natural latex products, and those most at risk are doctors, nurses, and other healthcare workers, food preparation workers, housekeepers, and hairdressers who wear latex gloves in their professions, as well as people who have undergone multiple surgeries.

Like other allergies, the severity of the reaction depends on prior sensitization, duration and level of exposure, and other factors. In mild cases, individuals develop contact dermatitis that appears 12 to 36 hrs. after contact with a latex product. Reactions usually appear on the hands where gloves were worn but can occur on any body part that contacted latex. In severe cases, exposed individuals experience immediate IgE (immunoglobulin E) antibody-mediated reactions, including itching, redness, swelling, and, sometimes, anaphylactic shock, a very serious and potentially life-threatening condition.

The problem starts with naturally occurring proteins in the sap of the Hevea brasiliensis rubber tree found in the Amazon basin. Although the milky sap contains hundreds of proteins, research studies indicate that only six cause allergic reactions.

Vystar Corp technology removes virtually all the allergy-causing proteins from natural rubber latex while retaining the material's barrier protection, elasticity, comfort, tensile strength, and fit. We conducted focus-group testing and found that healthcare workers were dissatisfied with gloves made of synthetic and petroleum-based substitutes, citing poor elasticity and fit, frequent tearing, odor, and higher cost. They described their “perfect” glove as being powder-free and made from ultralow-protein natural rubber latex.

Vystar's standardized ultralow-protein source material, Vytex Natural Rubber Latex (NRL) is produced using aluminum hydroxide (Al(OH)3), a protein-binding additive, absorbent, emulsifier, and antacid. The Al(OH)3 permits the exchange and complexing of antigenic proteins in the liquid phase of field latex sap emulsions before they are used to manufacture latex products. Importantly, the process maintains the lipid layer surrounding the latex particles, so it does not compromise the mechanical stability of the latex.

Protein removal is done at the source of the latex rubber — the harvesting sites in Southeast Asia. Because the process is done onsite and is relatively simple, additional costs for products made from Vytex NRL should be negligible.

In addition to reducing its antigenic potential, Vytex-produced products resist aging because the process also removes molecular species, which are vulnerable to breakdown over time. The extraction of proteins and other particulates from natural rubber latex also gives Vytex NRL products very low odor, an advantage for certain medical devices, and foam bedding and accessories.

Trials conducted by glove manufacturers show that products made with Vytex NRL have low antigenic protein levels and do not need washing or post leaching. This is particularly important for adhesives and other applications where leaching is not an option. Over 500 Vytex NRL trials have shown that the material's total and antigenic protein levels are below the modified Lowry's detection level.

Tests on Vytex NRL using the industry-standard American Society for Testing and Materials (ASTM) 6499-07 ELISA inhibition test method have also returned protein levels below ELISA detection levels for a wide variety of medical devices including exam gloves, condoms, surgical gloves, probe covers, and breather bags. Vytex is working with the ASTM Natural Rubber Subcommittee to establish a new category of ultralow-Hevea-protein natural rubber latex.

We are currently conducting trials with more than 45 manufacturers worldwide to substitute Vytex NRL for traditional latex or synthetic alternatives in exam and surgical gloves, condoms, foams and bedding products, adhesives (such as for food stickers), coatings, and other products. A U.S. condom manufacturer is in the process of obtaining regulatory approvals from the Food & Drug Administration (FDA) to market a condom made with Vytex NRL. A medical glove application has also been filed with FDA and is pending approval.