FDA bans powdered gloves beginning Wednesday, January 18, 2017
In late December 2016, the Food & Drug Administration (FDA) issued a final rule banning powdered gloves with an effective date of Wednesday, January 18, 2017. The FDA denied requests to delay the January 18th date after concluding that continued use of powdered gloves poses "unreasonable and substantial risk to patients and health care workers." The cause for the ban is the FDA’s determination that the “use of powder on medical gloves presents numerous risks to patients and health care workers, including inflammation, granulomas, and respiratory allergic reactions.” The FDA’s final rule is available here: https://www.federalregister.gov/documents/2016/12/19/2016-30382/banned-devices-powdered-surgeons-gloves-powdered-patient-examination-gloves-and-absorbable-powder.
The FDA’s ban applies to all powdered surgeon's gloves and powdered patient examination gloves (which includes those gloves worn by orthodontists and their staff) without reference to the type of material from which the gloves are made. The ban, however, does not apply to powder used in the manufacturing process (e.g., former-release powder) of non-powdered gloves, where that powder is not intended to be part of the final finished glove. As for absorbable powder used for lubricating a medical glove, it too is banned from use.
What To Do If You Have Powdered Gloves:
To comply with the FDA’s January 18, 2017 ban, you and your practice need to stop using powdered gloves and remove those gloves from your practice no later than the end of Tuesday, January 17, 2017. The FDA has made clear that the ban applies to powdered gloves already in commercial distribution and those already sold to the ultimate user, as well as to powdered gloves that would be sold or distributed in the future. So even if you have a supply of powdered gloves, you cannot continue using them in your orthodontic practice past Tuesday, January 17, 2017. Starting on Wednesday, January 18, 2017, all the gloves in your practice must be non-powdered gloves.
Confirmation That The Ban Applies to Dentists:
The FDA considered and rejected a comment to the proposed Rule arguing that the ban should not apply to dental practices. The FDA stated that it: "disagrees with the assertion that the risks of powdered gloves are not applicable to dental practice. Dentists and dental patients face the same risks as other medical practices in terms of the potential for powder exposure to open cavities or open wounds, and for powder, if used with NRL [natural rubber latex] gloves, to carry protein allergens. Several studies documenting the risks of powdered gloves in dental practices have been conducted, including Saary, et al., which identified that changing to low-protein and non-powdered NRL gloves reduced NRL allergy in dental students …. In addition, Charous et al., reported in 2000 that a dental office was able to reduce airborne NRL antigen levels to undetectable levels with the exclusive use of non-powdered NRL gloves, permitting a highly sensitized staff member to continue to work there ….. These studies, among others … indicate that the risks of powdered medical gloves apply to dental practice. Therefore, FDA has determined that the scope of the ban on powdered medical gloves should continue to include powdered gloves used in dental practice."
Should you have any questions regarding this topic, please feel free to contact the AAO’s Associate General Counsel, Sean Murphy, at 314-292-6523.