FDA Bans Powdered Gloves (Surgeon Gloves and Exam Gloves)
The US Food and Drug Administration (FDA) has released a final rule that bans powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove because these products present unreasonable and substantial risk to health care providers, patients and other individuals. The ban is effective January 19, 2017. The FDA only bans devices on rare occasions when necessary to protect the health of the public.
According to the FDA, medical gloves play a significant role in the protection of both patients and health care personnel in the United States. Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when conducting more limited interactions with patients. Various types of powder have been used to lubricate gloves so that wearers could don the gloves more easily.
However, the use of powder on medical gloves presents numerous risks to patients and health care workers. 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, the FDA believes that transition to alternatives in the marketplace should not result in any detriment to public health.
For more information, please see the FDA’s Medical Device Ban Webpage.
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