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December 17, 2016

FDA Bans Powdered Surgical and Patient Examination Gloves

The United States Food and Drug Administration (FDA) has issued final regulations banning the use of powdered surgical gloves, powdered patient examination gloves, and absorbable powder for lubricating surgical gloves.  The FDA found that while medical gloves play a significant role in protecting patients, health care providers, and other individuals in close proximity, powdered gloves are very dangerous for a variety of reasons.  These devices are associated with an extensive list of potentially serious adverse events, including severe airway inflammation, hypersensitivity reactions, allergic reactions (including asthma), lung inflammation and damage, or post-surgical  bands of fibrous scar tissue that form between internal organs and tissues (adhesions).  These adverse events have been attributed to the use of glove powder with all types of gloves.  In addition, aerosolized glove powder can carry proteins that may cause respiratory allergic reactions.  The state of the art of both surgeon's and patient examination gloves includes non-powdered alternatives that provide similar protection, dexterity, and performance that powdered gloves do, but do not carry any of the risks associated with glove powder.  Thus, a transition to alternatives in the marketplace should not result in any detriment to public health.  The act of banning a device is an important decision, and the FDA only takes this action on rare occasions when necessary to protect the health of the public.  The FDA has only banned one other medical device, prosthetic hair fibers in June 1983.  To read the FDA final regulations banning powdered gloves, use the first link below.  To read FDA general information on medical device bans, use the second link below.  To read FDA general information on medical gloves, use the last link below.

https://www.gpo.gov/fdsys/pkg/FR-2016-12-19/pdf/2016-30382.pdf  (FDA final regulations banning powdered gloves)

http://www.fda.gov/MedicalDevices/Safety/MedicalDeviceBans/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery  (FDA general information on medical device bans)

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/PersonalProtectiveEquipment/UCM056077?source=govdelivery&utm_medium=email&utm_source=govdelivery  (FDA general information on medical gloves)

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