- 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.
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
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 (FDA) has banned the use of powdered gloves in healthcare facilities as the aerosolized powder in natural rubber latex gloves can cause respiratory allergic reactions, airway inflammation and post-surgical adhesions.’
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.
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.
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?
have demonstrated that the powder used on medical gloves could:
foreign body reactions
- Be a
carrier of natural latex allergens
- Adhere to
peritoneal tissues after surgery leading to possible infection
respiratory allergic reactions (especially seen with natural rubber latex
- Cause granuloma and scar formation (especially corn starch)
Effects Attributed to the Use of Glove Powder
- Post-surgical adhesions (bands of fibrous scar tissue
which form in between internal organs and tissues)
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."
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
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.