The FDA has just announced their proposal to ban most of the powdered gloves in the country. The use of such gloves is going down, but still, they comprise an unfair and considerable risk of bringing illness or injury to providers, patients, and other individuals who happen to be exposed to them. This risk cannot be corrected through new or updated labeling.
The ban proposed by the FDA holds well for powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder that provides lubrication for the surgeon’s glove. According to the release presented by Jeffrey Shuren, M.D., Director of FDA’s Center for Devices and Radiological Health, “This ban is about protecting patients and health care professionals from a danger they might not even be aware of.” He stressed that the organizations takes bas very seriously and only place one when public health is at risk.
The gloves are sometimes powdered to ease putting them on and taking them off, but these are dangerous for a number of reasons. Natural rubber gloves with aerosolized glove powder can be dangerous because they carry proteins, which can potentially cause respiratory allergic reactions. Even though that is not the case with synthetic gloves, they are still associated with potentially serious adverse events. Some of these are severe inflammation in the airway, wound inflammation, and post-surgical adhesions. These side effects are generally attributed to glove powder being used with all types of gloves.
With updated labeling failing to correct these risks, FDA is proceeding with the proposal to ban the products altogether, and if finalized, this will remove them completely from the market. in the process of determining that these products are dangerous and carry unreasonable and substantial risk, FDA has gone through all available evidence, including a detailed review of the available scientific literature and comments received on a February 2011 Federal Register Notice.
Moreover, considering the critical role that medical gloves play in protecting patients and health care providers, the agency has done an economic analysis, which demonstrated that a ban would not cause a shortage, or significant economic impact. It is also not probable that the ban would affect medical practice, owing to the fact that there are many non-powdered options are available at this time.
FDA has found that the banning standard would not affect powdered radiographic protection gloves, or non-powdered surgeon gloves and non-powdered patient examination gloves, with the latter two belonging to Class I of medical devices.