Powdered gloves were once standard protective equipment in medical and examination settings. They were widely used by healthcare professionals for decades, primarily as a practical solution to a common problem faced by wearers. However, examining their safety reveals unintended biological consequences for both users and patients. This review clarifies the health risks associated with powdered gloves and explains the subsequent shift in regulatory standards.
The Composition and Function of Glove Powder
The powder most commonly used in these gloves was cornstarch, a natural, plant-based powder derived from maize kernels. This compound, sometimes treated and mixed with an anti-caking agent, served as the primary lubricant for medical gloves for years. Cornstarch replaced earlier powders like talcum powder and lycopodium, which had caused complications due to their mineral composition.
The primary function of the powder was to facilitate “donning,” or the act of putting the gloves on, which was challenging with traditional rubber gloves. Cornstarch acted as a lubricant, allowing the glove to slide smoothly over the skin, even when hands were damp or sweaty. This made the gloves easier and quicker to apply in fast-paced clinical environments. The powder also helped prevent the gloves from sticking together during storage and dispensing.
Health Risks Related to Powdered Gloves
Despite its inert nature, cornstarch powder presented a significant health hazard because it acted as a carrier for other substances. When latex gloves were used, the powder readily absorbed and carried natural rubber latex proteins. As the glove was removed, the powder would aerosolize, creating a cloud of airborne particles containing these allergenic proteins.
This airborne dispersion allowed both the wearer and nearby individuals, including patients, to inhale the latex proteins, leading to sensitization. This exposure is a major contributor to the development of Type I hypersensitivity, or latex allergy, which can cause symptoms ranging from skin irritation and asthma to life-threatening anaphylaxis.
Beyond allergic reactions, the powder posed non-allergic risks, especially in surgical environments. If cornstarch particles contaminated open wounds or were introduced into internal body cavities during a procedure, they could trigger a foreign body reaction. This involves the immune system responding to the powder particles as invaders, leading to inflammation.
The resulting inflammation was linked to severe post-surgical complications. These complications included the formation of granulomas, which are small areas of chronic inflammation, and peritoneal adhesions. Adhesions are bands of internal scar tissue that form between organs, potentially causing chronic pain, bowel obstruction, or infertility. The powder also increased the risk of surgical site infections and delayed wound healing.
Regulatory Status and Prohibition
Mounting scientific evidence detailing the risks of powdered medical gloves prompted a strong regulatory response in the United States. The U.S. Food and Drug Administration (FDA) issued a final rule banning the use of these products in healthcare settings. This ban applied specifically to powdered patient examination gloves, powdered surgical gloves, and the absorbable powder intended for lubricating a surgeon’s glove.
The final rule was published in December 2016 and became effective on January 18, 2017, removing these devices from the market. The FDA determined the risks associated with the powder were “unreasonable and substantial.” Labeling the product was deemed insufficient because the powder created an inhalation hazard for bystanders and could cause serious internal damage to patients.
This regulatory action was notable because it marked only the second time the FDA had issued a medical device ban. The agency cited the availability of safe and effective alternatives as a factor, ensuring the ban would not create a shortage of protective equipment. The prohibition covers all materials, including latex and synthetic gloves, because the cornstarch itself was the source of non-allergic complications like adhesions and granulomas.
Modern Powder-Free Alternatives
Following the ban, powder-free gloves quickly became the standard of care in medical and examination environments. Modern gloves utilize advanced manufacturing techniques to achieve the necessary ease of donning without cornstarch powder. These gloves are manufactured from materials like nitrile, neoprene, and powder-free latex, which mitigate the latex protein allergy risk.
To ensure the gloves can be put on smoothly, manufacturers employ one of two primary methods: chlorination or polymer coating. The chlorination process involves treating the glove’s surface with a dilute chlorine solution, which reduces surface friction and tackiness on the interior. This technique also significantly reduces the level of extractable latex proteins in latex gloves, further lowering the risk of allergic reactions.
The polymer coating method applies a thin layer of a synthetic material, such as hydrogels, to the inside surface of the glove. This coating acts as a dry lubricant, providing a smooth finish that allows the hand to slide easily into the glove. Both methods ensure that modern protective equipment meets the functional demands of healthcare professionals while eliminating the biological hazards associated with the former powdered variety.