AMARILLO, TX (KFDA) - The United States Food and Drug Administration is proposing a ban on many powdered gloves.
While usage of these gloves is decreasing, especially in the Panhandle, they pose a risk of illness or injury to health care providers, patients, and others who are exposed to them. The FDA said these risks cannot be corrected through new or updated labeling.
The proposed ban applies to powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's gloves.
"This ban is about protecting patients and health care professionals from a danger they might not even be aware of," said Jeffrey Shuren, M.D., Director of FDA's Center for Devices and Radiological Health. "We take bans very seriously and only take this action when we feel it's necessary to protect the public health."
Powder, usually in the form of cornstarch, is sometimes added to gloves to make them easier for health care professionals to put on and take off.
In natural rubber latex gloves, the aerosolized glove powder can carry proteins that can lead to respiratory allergic reactions; however, synthetic (non-rubber) powdered gloves do not pose this threat.
"The powder that's found in latex gloves will contain the protein and it can aerosolize the latex protein with the cornstarch or powder starch that's in the gloves and therefore, it can transfer it from skin to skin or even in wounds or in the air,"said Melissa Griffith, Family Nurse Practitioner at Allergy A.R.T.S.
The powder from inside these gloves can make their way into a patient's incisions and into a person's airways, which can cause severe airway inflammation, wound inflammation, and post-surgical adhesions (bands of scar tissue that from between internal organs and tissues).
"Primarily the allergic reactions are you can aerosolized reactions affecting your lungs including wheezing, shortness of breath, coughing, and even anaphylactic reactions where you can have sneezing, itchy watery eyes, or reactions where your throat may feel like it's closing up," Griffith said. "You can also have other reactions on the skin like rashes, hives, and itching as well."
The FDA said these side effects have been attributed to the use of glove powder with all types of gloves.
Since these risks cannot be corrected through new or updates labeling, the FDA is moving forward with the ban. If it is finalized it would remove them from the marketplace completely.
An economic analysis conducted by the FDA shows a powdered glove ban would not cause a glove shortage and the economic impact of the ban would "not be significant."
They feel the ban is not likely to impact the medical practices, because many non-powdered gloves are available for purchase.
While many medical professionals who use these gloves will have to make a change many medical professionals in our area such as doctors and dentists have already made the switch.
"We actually don't use latex gloves because of the patients that do have latex allergies and because we are an allergy clinic we are very acutely aware of that, but in general practice we may not know if a patient has latex allergies until we've already caused the problem," Griffith said. "So, we don't use them as a standard of practice."
Most homeowners will not have these types of gloves at home in their medical kits, but Griffith said to avoid latex gloves just to be safe.
"There are some gloves that have synthetic material, in other words they are non-latex gloves, those you may find at other stores or pharmacies that you can get for home use and those may or may not have powder in them, but if there is ever a concern then they would want to purchase the ones that don't have powder in them just to be certain," Griffith said.
The proposed rule is available online for public comment until Jun. 20, 2016.