2 firms respond to US attempt to ban NR latex medical gloves

By Miles Moore, Crain staff (R&PN)

Washington DC -- Responding to an effort to get medical gloves made of natural rubber or powdered with cornstarch banned, one glove maker defended its work to reduce allergy dangers, and another touted synthetic rubber gloves.

Ansell Healthcare and Showa-Best Gloves Inc. commented on an April 25 petition by consumer advocacy group Public Citizen to the Food and Drug Administration. Public Citizen-which sought a similar ban in 1998-said a continuing allergy crisis is spurring the organisation to renew its call for a ban on powdered medical gloves, and expand that call to all natural rubber latex medical gloves.

“The dangers posed by powdered surgical and patient examination gloves have been widely recognised throughout the medical profession and the world for many years and are indisputable,” Public Citizen said.

Airborne powder from medical gloves can cause serious allergic reactions in sensitised workers even if they themselves aren't wearing those gloves, the group said.

Even powder-free latex gloves pose serious threats to allergic workers and patients, according to the petition. The FDA's own database shows the death of one surgical patient and severe reactions from nine health care workers caused by powder-free gloves since 2205, it said.

The FDA rejected the original Public Citizen petition in July 1999, according to Public Citizen. The agency argued that a ban on powdered gloves would not address exposures to latex gloves with high levels of proteins and might compromise the availability of high-quality medical gloves.

Instead, the FDA proposed labeling latex gloves with warnings about possible allergic reactions.

“More than a decade later, these proposed regulations have not been finalised (although promulgation of such regulations would not have been sufficient to address the dangers posed by powdered gloves),” Public Citizen said. “The FDA's prolonged failure to take actionàdemonstrates an astonishingly reckless and inexcusable disregard for the health and safety of patients and health care workers.”

Germany banned powdered latex gloves in 1998, and by 2002 the number of suspected cases of latex allergy in that country dropped 80 percent, the petition said.

Since latex allergies became an acknowledged worldwide problem in the late 1980s, virtually every maker of protective gloves has worked to circumvent allergies through removing proteins from latex, not powdering gloves or using alternative materials. Some startup companies have formed, such as Arizona-based Yulex Corp., which makes hypoallergenic rubber latex from the desert shrub guayule.

From its European headquarters in Brussels, Ansell Healthcare said it has spent years working to make substantial reductions in the amount of proteins in its NR latex gloves.

“The vast majority of healthcare workers and patients can use natural rubber latex gloves safely,” Ansell said. 'However, it must be noted that Ansell would never recommend the use of natural rubber latex gloves with health care workers and/or patients that have a history of latex sensitivity.”

When there is no opportunity to assess a patient's medical history, such as in the emergency room, Ansell also recommends against the use of natural rubber latex gloves, the company said.

Ansell offers a full range of non-latex alternatives in medical gloves, the company said.

Showa-Best Gloves., the Menlo, Ga.-based glove maker, invented nitrile gloves when latex allergies first became a concern, and still believes they are the best solution to allergy problems, according to Donald F. Groce, technical production specialist with Showa-Best.

“Powder-free latex can still cause anaphylactic shock,” Groce said. “”Low-protein latex would cut down on allergic reactions, but not eliminate them.”

Many hospitals have switched to vinyl gloves, which are cheaper than latex or nitrile and don't cause allergic reactions, according to Groce. But vinyl doesn't offer the barrier protection from blood-borne pathogens that nitrile does, he said.

“In the medical market, price is everything,” he said. “We make our nitrile gloves in the US, which means their price is higher than gloves made in Malaysia or China. For that reason, we don't have much of a medical market for our nitrile gloves.”

From Rubber & Plastics News (A Crain publication)