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Our Glove Buyer's Guide 2007 features suppliers of surgical and exam gloves with a wide variety of latex and synthetic options. With so many viable choices, what do you need to know when you shop for gloves?

"It’s not just fit, feel and comfort," said Carolyn Twomey, RN, vice president of clinical affairs for Norcross, GA-based, Mölnlycke Health Care US. "It’s, how low is the protein? Are your gloves non-pyrogenic? Are they powder-free? What are your viral penetration testing results? Are your gloves tested against chemotherapeutic agents? There are numerous questions that I would recommend asking when buying gloves. Ultimately every hospital has to make its own decision, the smart clinical decision."

With a focus on becoming "latex-safe" versus "latex-free" and by taking advantage of innovative synthetic offerings, hospitals can provide premium gloves at manageable prices and meet the needs of all of their employees and patients. AORN’s 2006 Latex Allergy Guideline supports the concept of "latex-safe" as do many prominent healthcare organizations.

"Because there is no cure for a latex allergy, preventative measures, such as what is outlined in AORN’s Latex Guideline, are the key to eradicating the risk of latex allergic reactions for caregivers and patients," said David Parks, general manager, global business management, Kimberly-Clark Health Care (Roswell, GA).

"Latex-safe is very specific," said Twomey. "It means that you’ve made every effort you can to reduce exposure to latex proteins in your environment. And it is very specific in that it involves going powder-free and low-protein in your gloves, and having synthetic alternatives for not only your gloves, but all of your other products in the hospital that have latex in them, and there are tons."

By recognizing what it is about latex gloves that cause allergic reactions, facilities can easily minimize the risk of such adverse events.

"Latex protein allergy is caused by the use of latex gloves that are high in residual proteins and excessive powder," explained Dr. Esah Yip, director of the Malaysian Rubber Export Promotion Council. "The protein level of these gloves could be as high as about 2000 micrograms/gram of residual proteins, which could easily sensitize especially the atopic individuals, and could elicit allergic reactions in them." She adds, "improved glove manufacturing technologies have now made it possible to produce gloves that have protein levels as low as less than 50 micrograms/gram. Gloves now may have a low controlled upper limit of powder or [are] powder-free."

Peter Sewell, director of product development for Tronex (Parsippany, NJ), comments that, "ten and twenty years ago there was some limited understanding about latex (glove) product development, quality control, and manufacturing standards, and the onus was on the manufacturer to decide on how to develop and invest in its capabilities to best minimize and manage extractable protein levels, its respective glove production, and ability to stay ahead of the ever evolving FDA recommendations. In the end, those who did the best at managing this process, which also includes incorporating the use of premium grade USP powders, effective leeching processes and the highest quality water with precision temperature and duration controls, produced the safest and highest quality product."

Tronex manufactures a wide range of latex gloves and synthetic glove products designed to closely replicate the many performance advantages of latex itself including Tronex New Age Nitrile Examination Glove, Tronex "Syntech" Examination Glove, and Tronex "Synthetic + Memory" Vinyl Examination Glove.

Ansell Healthcare‘s North American clinical consultants, who are independent from the company’s sales team, present educational programs in hospitals as well as lead the Ansell Glove Management Program. The program helps facilities manage their glove inventory and usage, "not only to be as cost effective as possible, but also to maximize the facility’s objectives which might include to be a latex-safe or latex-free facility," said Diego Rodriguez, marketing director, Ansell Healthcare (Red Bank, NJ). "The program also focuses on using the right glove for the right task. We find that a lot of times people are not using the glove correctly or not using the right material for the task at hand."

Ansell offers a full line of latex-free glove options, and the company also recently released an official statement renewing its commitment to latex gloves. Among Ansell’s latex-free offerings is the DermaPrene Ultra, a neoprene surgical glove that is not only
latex-free to eliminate the possibilty of a Type 1 allergy, but also accelerator-free to eliminate the risk of Type 4 allergy. Some people are allergic to the chemicals in accelerators used in the manufacturing process.

"A facility might go to great lengths and even financial expenditures to address Type 1 allergy, but not make the effort to minimize the risk of Type 4 allergies," said Rodriguez.

Twomey notes that in addition to being low in proteins and powder-free, Mölnlycke’s gloves have also been tested for pyrogens and endotoxins that could potentially cause adverse reactions in patients. She explained, "there are so many products in the medical market that are required to be pyrogen-free such as implants, ocular lenses, IV tubing, IV catheters, etc., yet the FDA has never required gloves to be pyrogen-free. Think about that – when you’re having surgery you sometimes have multiple pairs of hands inside your body. So the FDA established a testing methodology for pyrogens, however it is not required at this time. We’ve consistently tested our gloves, and we continue to test under the new methodology because we believe it is another safety factor in our gloves, they are non pyrogenic."

Mölnlycke’s Biogel Eclipse is considered a "deproteinised" glove. According to Twomey, 90% of the latex proteins are removed from the raw latex liquid prior to the manufacturing of the glove and under the testing methodology currently available, the Eclipse glove tests below detectable limits for proteins.

"Natural rubber latex in the form of low-protein latex gloves should fit into hospital’s latex-safe policies very well," said Dr. Yip. "The superior barrier performance of latex gloves is well acknowledged. Their use has been shown by many hospital studies to not only significantly reduce the incidence of allergy, but also enable many latex allergic individuals who wear non-latex gloves to work alongside their co-workers using these low-protein gloves, and with no ill effects. Some studies even reported that replacing high protein gloves with the low-protein variety resulted in cost savings ranging from $10,000 - $200,000 per year."

On the synthetic front, "as better alternatives to latex in terms of comfort, performance, and value become available, the case for facilities to convert to latex-free solutions will become very compelling,"said Parks. (For a case study highlighting a successful system-wide conversion to Kimberly-Clark’s Sterling Nitrile glove see "WHAT WORKS.")

"The range of latex-free options is better and broader than ever," said Tripp Amdur, president, Medline Gloves Division (Mundelein, IL) . "Nitrile gloves have improved in quality and have fallen in price over the last four or five years. Meanwhile, Medline has led the introduction of a range of 2nd and 3rd generation vinyl gloves that offer much more durability and much improved fit and comfort over the vinyl gloves of the past. These gloves generally cost the same or less than PF Latex gloves, and so have been very popular among hospitals that are looking to go latex-free but are unable to increase their exam glove budget."

Twomey explains that beyond simply providing alternative products, "latex-safe" means having policies and procedures so that you know how to take care of your patients and your staff who have latex sensitivities. It means educating patients about latex allergies and how the facility is being proactive to keep them safe, as well as educating staff on a fairly regular basis on how to manage a patient with a latex allergy and what latex-safe entails."

"It’s all of those components that fit together to give you a latex-safe program in your hospital," emphasized Twomey. "The AORN Latex Allergy Guideline, and the evidence in the literature tells you it’s virtually impossible to go latex-free. Because latex-free implies that it’s not just your gloves. There are catheters, backings on electrodes from a heart monitor, adhesives, there are just so many things…to say that you’re latex-free is virtually impossible to achieve."

Photo by David Kadlubowski A sample of Yulex latex derived from the desert plant guayule is poured.

New developments in latex production aimed at providing low-protein alternatives, include a domestically grown natural rubber latex (NRL) known as Yulex, derived from the desert plant Guayule. Manufactured and marketed by Carlsbad, CA-based Yulex Corporation, the company recently paired with the United States Department of Agriculture (USDA) to ramp up production of Yulex and work on ways to increase the plants’ rubber yield.

The biggest advantage for hospitals and end-users is that this new natural rubber guayule latex provides the same desirable performance characteristics of Hevea latex derived from tropical rubber trees, yet does not pose the serious health risks (latex allergy) as NRL from Hevea. Expected to be priced lower than high-end synthetics, Yulex latex contains less than 2% of the protein content of Hevea latex and its proteins are different than those in Hevea and does not cross-react. Clinical data suggests the latex contains no "super sensitizing" proteins like those in Hevea.

As a renewable resource, Yulex exceeds ISO & ASTM raw material tests for strength, flexibility, viral barrier protection and resistance to heat, moisture and deterioration. Recently, the American Society for Testing and Materials (ASTM) created a new latex category which specifies, for the first time, safety standards based on protein content. The ASTM D1076-06 standard defines a new Category 4 NRL that includes Guayule or other NRL containing less than 200 micrograms total protein per gram dry weight of latex and no detectable protein by the ASTM D 6499 standard method for quantifying Hevea antigenic protein. Yulex latex is now a natural rubber Guayule latex (NRGL) and is no longer in the same category as NRL.

According to Jeffrey Martin, CEO and president of Yulex Corporation, "Yulex latex is currently being sold and distributed by Centrotrade Rubber USA Inc. and Centrotrade Deutschland GmbH to medical device manufacturers."

Another innovation for latex gloves come from Vystar Corporation (Atlanta, GA). The company’s Vytex is a natural rubber latex in which the antigenic proteins that trigger allergic reactions are deactivated without reducing elasticity, potentially making it safe for use by most people who are allergenic-protein sensitive. Ongoing test results show that the Vytex technology reduces antigenic proteins to levels considered undetectable by the most widely used standard tests.

Vystar has partnered with Revertex Malaysia to produce Vytex "safe latex". "We have a long list of manufacturers who have requested samples in various industries," said Bill Doyle, president of Vystar. "Our target for gloves in the U.S. would be the fourth quarter of this year," he added. He anticipates that pricing for gloves made with Vytex will be highly competitive with synthetics. The company says that both surgeon gloves and exam gloves will be among the first medical products to market made from Vytex.