Glove manufacturer Sempermed USA (Clearwater, FL) recently posted an urgent bulletin on its Web site reporting dramatic increases in the price of its raw materials – the two key components of which are latex and oil.

Dr. Katrina Cornish, Yulex Corp.,
examines vials of Guayule

Sempermed’s bulletin noted that "the rubber used for disposable latex gloves is harvested and traded per metric ton on the open market and is referred to as "wet" latex. The daily price of wet latex can be found on the Malaysian Rubber Board’s website. As of February 6th 2006, wet latex was trading at $1,414.70 per metric ton. This is an increase of 19% since January 2006 and over 79% from the beginning of 2005. The costs involved in the production of latex and synthetic gloves are invariably linked to the price of oil. The price of a barrel of oil traded at $67.86 on January 31, 2006, an increase of over 50% since the beginning of the 2005.

"In addition, the increase of oil and fuel prices drive up freight costs, which directly affects the manufacturer’s ability to deliver their products," Sempermed continued. "Companies can offset some of these costs in other areas, but price increases are inevitable."

This glove was made by a major surgeon’s glove manufacturer using Vytex natural rubber latex.

Meanwhile, in late January, Bloomberg News reported, "The Malaysian Rubber Glove Manufacturers’ Association said it plans to raise prices by at least 8.7 percent in line with higher prices of natural rubber and warned that rubber prices will stay high. Natural rubber traded on the Tokyo Commodities Exchange has gained 29 percent over the past six months to 234.8 yen ($2) a kilogram, near a 21-year high." The price of rubber is likely to stay high in the current quarter as "continuous rains have disrupted supply," the association stated.

Like Sempermed, most glove manufacturers either have already raised prices or are expected to do so after exhausting their options for trimming costs in manufacturing processes or elsewhere. In addition, a number of glove makers are introducing revamped synthetic alternatives that are designed to more closely mimic the strength and performance properties of latex but sans the proteins that are linked to causing allergic reactions and topical sensitivities in end users and patients.

"These increases have affected the cost of manufacturing all gloves, but latex has been especially hard hit," said Tripp Amdur, president of Medline Industries’ Glove Division (Mundelein, IL). "The latex itself constitutes about half the cost to manufacture an exam glove, and latex is now up 89 percent since January 2005. This has led inevitably to higher costs in the marketplace for latex gloves, although we’ve only recently begun to recoup a small portion of the costs that have been absorbed. Higher latex costs inevitably encourage customers to look carefully at latex-free options. There has already been a trend towards latex-free gloves. Higher latex costs will only strengthen that trend."

Cardinal Health Inc. (Dublin, OH) also has felt the pricing pressure, implementing a number of changes to "maximize the efficiencies of our manufacturing facilities," said Donna Gaidamak, media relations manager. "In the past two years we have seen Polyisoprene prices more than double, natural rubber latex prices have increased 65 percent and energy costs have increased 68 percent since 2002. Despite all of our efforts, we are working with our customers, including group purchasing organizations, on pricing issues. We recently raised our prices on exam gloves with a major GPO and our customers know that we will have to change the pricing going forward."

Ansell Healthcare Products LLC (Red Bank, NJ) has tried to blunt the sting of raw materials pricing spikes, too. "Ansell has implemented cost savings measures in factories and suppliers to help contain rising costs, including shipping in larger, but fewer containers to save on fuel, and recommending to customers to move to latex-free products to ease the burden of pricing pressure," said Carol Carrozza, vice president of marketing, Ansell Healthcare’s Consumer and Professional Division. "In some cases Ansell has no choice but to raise pricing on latex exam gloves, modestly."

To start, Kimberly-Clark Health Care (Roswell, GA) simply phased out a segment of its product line. "Early on, we eliminated a product line from the lower end of our latex product group," said John Amat, vice president, global sales and marketing. "We did that because we were unwilling to compromise the quality of our product and could not continue to absorb the increase costs and lose money. The driver, though, was a refusal to comprise on quality, so we moved customers from the lower end line to the next level of products.

"Moving forward, we continue to see increases in latex and energy prices," he continued. "We’ll continue to evaluate options in the face of these rising costs and adjust pricing as needed to maintain the quality of our products. We continue to leverage our scale, as well as look for opportunities to apply existing and developing technologies to our processes to reduce our manufacturing costs. However, implementation of these technologies occurs only if we’re assured that product quality is not compromised."

One way glove makers are addressing latex concerns is offering synthetic alternatives. Some of the more common synthetics in use today include Nitrile, Neoprene and Polyisoprene. On the pricing scale, Neoprene is less expensive than Polyisoprene but more expensive than Nitrile, explained Amdur.

However, a third option is emerging in the choice between natural rubber latex and synthetic models. One is a domestically grown natural rubber latex called guayule, manufactured and marketed under the brand name Yulex by Yulex Corp. (Carlsbad, CA). The company touts the material for use in gloves, catheters and other medical devices – the first products of which are expected to hit the market later this year, according to Jeff Martin, CEO.

Martin told Healthcare Purchasing News that the Yulex material actually provides a lower-cost alternative to synthetics. "Yulex latex is not based on a commodity pricing model and is priced independent of fluctuations in natural rubber latex and petroleum prices," he said.

Although Martin noted that "the price strategy is determined by the glove makers, but generally speaking, will be below that of most synthetic alternatives.

"Synthetic materials are petroleum-based products and with oil prices reaching and sustaining historic highs, price pressure is being felt on synthetic glove materials. In addition, the higher the quality of a synthetic latex alternative, the higher the price, so Yulex latex is designed initially to compete with high end synthetics with a lower price and higher performance. It is also cost effective because the acquisition costs are below those of many synthetic materials utilized for surgical gloves, condoms and specialty catheters," he said.

In addition, the extremely low-protein count in the guayule latex lowers the risk of allergic reactions, which makes it safe for healthcare workers and patients alike, according to Martin.

"The proteins contained in guayule are not similar to those contained in tropical latex; the non-cross reactivity of guayule latex is well documented," Martin said. "In addition, Yulex latex contains less than 5% of the protein content of ‘processed’ Hevea latex. Clinical data suggests guayule latex contains no ‘super sensitizing’ proteins. It continues to undergo rigorous immunological and allergy testing to validate its safe use for latex allergy sufferers and the general population," said Martin.

Being a natural product, Yulex competes effectively with synthetics for its durability, tensile strength, donability and comfort. "You can’t beat mother nature," emphasized Martin. "It is unlikely that a manmade material will ever be as strong, as elastic, as long-lasting and as tolerant of extreme temperature fluctuations as a natural rubber-based product. Yulex latex products exceed all ASTM Standards for strength, elongation and modulus for both natural rubber latex and synthetic alternatives. Yulex latex is an ideal balance of physical properties offering a very stretchy, high tensile strength product with a low modulus. This combination of features offers the healthcare practitioner the benefit of a strong protective barrier yet combines a soft, flexible hand with enhanced tactile sensitivity. This combination of properties is not available with synthetic polymers.

"You might look for Yulex initially being available for surgical gloves," Martin added. "Manufacturers have expressed a strong interest in surgical gloves and catheters where performance is essential." In fact, "there is high interest from a number of well-known medical device manufacturers."

While many of the major glove manufacturers express an interest in alternative rubber sources, they are concerned about pricing and availability of the material.

"As a global company, we are constantly monitoring and evaluating alternatives to current glove materials such as guayule and de-proteinized rubber latex, and developing glove technologies that address our customers’ needs. We have considered guayule and will continue to assess the value of bringing this material to the marketplace," said Cardinal Health’s Gaidamak.

According to Medline’s Amdur, "We are familiar with guayule, but we have not carefully explored using it. It seems to be relatively expensive and does not jump out as having advantages compared to Polyisoprene."

Said Amat: "This is certainly an area of high interest for Kimberly-Clark. We haven’t focused heavily on guayule mainly because of the concern over whether there exist enough crops to supply a large demand. What we’ve been doing is looking at synthetic materials that we could produce at the lowest possible costs and at the same time produce a glove that we feel comfortable about meeting the expectations of our current latex customers."

Ansell is also looking at alternative rubber sources. "We have them in development in our proprietary stage gate process," said Carrozza.

Another alternative set to hit the gloves market is Vytex, which is being promoted as a "protein-free natural rubber latex." The maker of Vytex, Vystar Corp. (Atlanta) has developed a patented method for the deactivation of the antigenic proteins (AP) in liquid natural rubber latex that involves the quasisequestration of these proteins. "Our process works with proteins pure and simple," said Bill Doyle, president and chief operating officer.

"Based on primary market research, Vytex natural rubber latex could fit the need for a glove that performs like current latex gloves, which are greatly preferred, but without the antigenic protein levels," said Doyle.

"Our goal is to provide the same protection and comfort as latex gloves with a very low protein level from the earliest raw material stage. Initial test data reveals that gloves made from Vytex natural rubber latex have very low antigenic protein levels and improved physical properties," he continued.

Kimberly-Clark Health Care
STERLING Nitrile exam glove

Kimberly-Clark Health Care (Roswell, GA) recently introduced its STERLING Nitrile exam glove that it’s marketing as a house-wide replacement for latex exam gloves. The manufacturing process of STERLING allows for a high tensile strength of 42 mpa (as opposed to some competitive gloves with tensile strengths of 14-27 mpa) in a thinner glove. "Kimberly-Clark researchers developed a new method of utilizing synthetic nitrile polymer along with an innovative proprietary compounding that results in a higher tensile strength, consistent formation and uniform thickness to ensure maximum barrier protection and comfort. According to trial usage, caregivers prefer Sterling Nitrile’s reduced glove thickness because it lessens hand fatigue and provides better flexibility and touch than latex," said John Amat, vice president, global sales and marketing.

A key selling point for the Sterling Glove lies in its packaging. "Because of the glove’s unique properties, Sterling Nitrile packaging can hold 50 percent more gloves than a standard size case (1,500 versus 1,000). In addition to environmental and space-saving benefits, having additional gloves in the case reduces the time that it takes to change a glove box in an exam room (approximately 30 seconds)That’s important because over the course of a year, facilities could potentially save 167 hours," said Amat. Reduced environmental waste and disposal costs are another advantage of the Sterling. "An average size facility could potentially save up to 20 tons of medical waste every year by standardizing with Sterling Nitrile facility-wide," he said. The Sterling package design is available in a 500 Count Countertop Dispenser with a dual-sided design that helps prevent contamination of gloves through pull-by-cuff dispensing for rapid donning with minimal contact with the glove or box opening.

Neolon 2G surgical glove from Medline

Medline’s new Neolon 2G surgical glove made of Neoprene promises improved fit and feel. Medline is also launching a new blended synthetic glove that will be coated with Aloe for added improvement over the Neoprene. "On the exam side, our new Universal 3G stretch vinyl synthetic glove has grown in popularity far faster than we had ever imagined," said Tripp Amdur, president of Medline Industries’ Glove Division (Mundelein, IL). "We have launched a new Aloetouch version, coated on the inside with Aloe Vera, that we expect will grow just as quickly. We also have a new, softer nitrile glove that has proven to be very popular."

Medline has also been having such success with its Sensicare Polyisoprene surgical gloves that it recently expanded its Polyisoprene facilities in order to triple production capabilities. According to Amdur, "Polyisoprene is nearly identical to natural rubber latex in terms of its chemical structure, but it is 100% synthetic and contains none of the proteins that can cause latex allergies. Most surgeons would love the chance to go latex-free, but they are not willing to sacrifice any of the fit and tactile sensitivity latex provides. A good Neoprene glove can be pretty close to latex, but it is not the same. However, with Polyisoprene, you have a glove that feels and works just like natural latex. As our supply of Polyisoprene improves with the completion of our new expansion project, we will come out with new Polyisoprene surgical gloves to complement the Sensicare brand."

Ansell Derma Prene PI surgical glove

Ansell Micro-Touch Nitrile EP exam glove

Ansell Healthcare Product’s (Red Bank, NJ) newest gloves include the MT Nitrile EP exam glove with a longer cuff for extended forearm protection, and a Polyisoprene powder-free surgeon’s glove, called the Derma Prene PI. The latest in Ansell’s Micro-Touch line, the powder-free MT Nitrile EP is textured to enhance grip, FDA-approved for handling chemotherapy drugs and provides excellent chemical and puncture resistance. The reduced thickness of Ansell’s Derma Prene gloves provides enhanced tactile sensitivity in the fingertips, and makes double gloving easier and more comfortable. A smooth finish aids instrument and suture handling.

To address the needs of clinicians who double glove, Cardinal Health (Dublin, OH) recently unveiled Esteem Blue and Protegrity Blue with Neu-Thera, two surgical gloves specifically designed for use in undergloving. Cardinal’s Esteem Blue gloves are made from Polyisoprene and are powder-free. Cardinal’s new Protegrity Blue is made of natural rubber latex and has a smooth grip that makes double gloving easier and contains the same protection and moisturizing benefits of Cardinal’s Neu-Thera gloves. Both gloves can also be used as a stand-alone surgical glove. Cardinal Health has also introduced five new exam gloves, said Donna Gaidamak, media relations manager.

Sempermed Syntegra SIS surgical glove