Medical gloves are available as either powdered or non-powdered kind.
FDA has proposed a ban on powdered surgeon and patient examination gloves. The ban also applies to the absorbable powder used for lubricating surgeon’s gloves.
The ban would not apply to powdered radiographic protection gloves, because FDA is not aware of any powdered radiographic protection gloves that are currently on the market; in addition, non-powdered surgeon gloves and non-powdered patient examination gloves will not be included in the ban and will remain Class I medical devices.
Gloves used during various medical procedures and examinations are basically disposable gloves, which are meant to minimize cross-contamination between caregivers and patients. They are usually made of various polymers like latex, vinyl, amongst others and are lubricated or powdered with materials including cornstarch and talcum powder.
The powders are used on gloves to facilitate ease of wear and removal as well for doctors, nurses and other healthcare professionals and to prevent them from sticking together during the manufacturing process and later.
The U.S. Food and Drug Administration announced March 21 it intends to ban most powdered gloves in the United States. Powdered gloves have been a concern for many years; FDA was being requested in the 1990s to ben them, and “low-powder” and “powder-free” glove alternatives became popular.
The U.S. Food and Drug Administration (FDA) recently announced a proposal to ban most of the powdered gloves in the United States, citing a valid reason that these gloves could pose an unreasonable and substantial risk of illness or injury to many, including health care providers and patients.
Before making this proposal, FDA first systematically analyzed available scientific literature on the use of the powdered gloves and the comments received on a February 2011 Federal Register Notice.
The proposed ban includes everything from powdered surgeon’s gloves, powdered patient examination gloves to absorbable powder for lubricating a surgeon’s glove. However, non-powdered surgeon gloves and non-powdered patient examination gloves are exempted from the ban and will continue to be Class I medical devices.
Studies have shown that unlike the synthetic (non-rubber) powdered gloves, the aerosolized glove powder in natural rubber latex gloves could carry proteins that could potentially cause some respiratory allergic reactions.
Why is It Not Good to Use Glove Powder?
Research studies have demonstrated that the powder used on medical gloves could:
Facilitate foreign body reactions
Adhere to peritoneal tissues after surgery leading to possible infection
Be a carrier of natural latex allergens
Cause respiratory allergic reactions (especially seen with natural rubber latex gloves)
Cause granuloma and scar formation (especially corn starch)
Side Effects Attributed to the Use of Glove Powder
Severe airway inflammation
Post-surgical adhesions (bands of fibrous scar tissue which form in between internal organs and tissues)
FDA is of the opinion that new or updated labeling would not take care of the risks associated with the use of the powdered medical gloves. Hence, they propose to ban the use of these products, which if finalized could eventually remove all of them from the market. Also, the FDA stated that the prohibition would not lead to glove shortage by any means and the economic impact of the ban would not be significant. Impact on medical practice would be minimal due to the continued availability of many non-powdered gloves in the market. They arrived at this conclusion after a thorough economic analysis.
Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health commented, “This ban is about protecting patients and health care professionals from a danger they might not even be aware of. We take bans very seriously and take action only when we feel it’s necessary to protect the public health.”