FDA's December 19, 2016 final rule banned powdered surgeon's gloves, powdered patient-examination gloves and absorbable powder used to lubricate a surgeon's glove. The agency determined that their unreasonable and substantial risks could not be corrected by labeling. January 18, 2017 was the effective date; the publication date was not itself the start of the ban. [2016-30382][2016-06360]

The product boundary is precise. Non-powdered surgical and examination gloves remain in their revised classifications, while powdered versions move into the banned-device listings. Powdered radiographic gloves are outside this rule. Non-powdered does not mean an absolute absence of every particle: the final definitions permit residual powder from manufacturing, rather than powder incorporated for other purposes. [2016-30382][2016-06360]

The March 22 proposal adds historical context to the decision. FDA described a 1997 report that reviewed clinical and experimental evidence, MedWatch adverse events and commercial information about available gloves and costs. The agency's discussion of that earlier market belongs to 1997. It does not independently establish prices, shortages or the availability of particular products in December 2016. [2016-30382][2016-06360]

The final rule's effective-date section covers devices already in commercial distribution and already sold to users, not only future shipments. Consequently, a simple distinction between old inventory and new purchases would misdescribe its scope. The two documents are proposal and final stages of a single FDA rulemaking. They establish the categories, rationale and timing, but not an individual patient's risk or an observed reduction in injuries after implementation. [2016-30382][2016-06360]

Source documents

  1. Banned Devices; Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glovehttps://www.govinfo.gov/content/pkg/FR-2016-12-19/html/2016-30382.htm
  2. Banned Devices; Proposal To Ban Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glovehttps://www.govinfo.gov/content/pkg/FR-2016-03-22/html/2016-06360.htm