A mandatory warning leaves a product available for purchase; a ban changes the available choice. FDA chose the latter in its December 19, 2016 final rule on powdered surgical gloves, powdered patient-examination gloves and absorbable powder for lubricating surgical gloves. The agency concluded that labeling could not correct their unreasonable and substantial risks. [2016-30382][2016-06360]

The rule's design matters for substitution. It retained classifications for non-powdered surgical and examination gloves while moving their powdered counterparts into banned-device listings. Powdered radiographic gloves were outside its coverage. That is a defined product boundary, not a prohibition on all glove suppliers or every glove made from latex. It also does not establish that any particular supplier would gain sales. [2016-30382][2016-06360]

The March 22 proposal supplies the market-history contribution. FDA described its 1997 review of clinical and experimental evidence, MedWatch events and commercial information about sources, types and costs of gloves. The agency's earlier assessment of available alternatives belongs to that period. Historical supply concerns cannot be carried forward as a measured December 2016 shortage or used to predict replacement prices. [2016-30382][2016-06360]

January 18, 2017 was the final rule's effective date, covering already-distributed and already-sold devices as well as future transactions. Existing stock was not a general escape from the new product boundary. The market question is how purchasers and suppliers respond to a narrower permitted choice; these documents do not answer it with observed prices or sales. They are successive stages of one FDA policy chain, not independent evidence of a commercial outcome. [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