UPDATE: The “Draft Guidance for Industry and FDA Staff – Recommended Warning for Surgeon’s Gloves and Patient Examination Gloves that Use Powder,” referenced in this post, was withdrawn on April 27, 2015.
The problems associated with powdered medical gloves are well documented. The FDA first issued a Medical Glove Powder Report back in 1997, warning of adverse health events that included dyspnea, respiratory problems, allergic reactions, and granuloma formations.
Research into glove related latex allergies found some major problems associated with the cornstarch powder used in latex gloves to facilitate donning.
- The powder binds to the latex protein in the glove, allowing the antigen to reach the wearer’s skin more easily.
- Body sweat inside latex gloves may make latex proteins soluble, allowing absorption through the skin and sensitizing the wearer.
- The action of donning and removing powdered latex gloves releases this cornstarch powder into the air, in effect aerosolizing the latex protein which is then inhaled by workers.
Powder in non-latex gloves, such as nitrile, vinyl and polychloroprene, can also cause serious problems.
- Powder can act as a vehicle to transport infectious microorganisms.
- If powder gets in a patient’s wound, it can interfere with local resistance to infection.
- Glove powder can also lead to painful dermatitis on the wearer’s hands, creating cracks and lesions that break the natural skin barrier and allow microbial access to the body.
- Powder can also absorb and aerosolize disinfectants, drugs and other chemicals that come into contact with the glove.
The FDA feels the concerns are serious enough to warrant the following recommended warning label on boxes of medical gloves:
Warning: Powdered gloves may lead to foreign body reactions and the formation of granulomas in patients. In addition, the powder used on gloves may contribute to the development of irritant dermatitis and Type IV allergy, and on latex gloves may serve as a carrier for airborne natural latex leading to sensitization of glove users.
The FDA powdered glove draft guidance was issued on February 2, 2011, and we are currently in the 90-day comment period before it decides whether, and in what form, it will make the guidance final.
Due to the risks associated with powder in medical gloves, the healthcare industry has been transitioning to powder-free exam gloves. We support their efforts to provide the safest environment for their patients and providers. All HandPRO nitrile exam gloves are powder-free.