FDA is proposing to ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s gloves. The Agency determined that an unreasonable and substantial risk of illness or injury may occur from using these medical products and the risk cannot be corrected or eliminated by labeling or a change in labeling.
Electronic comments are encouraged for docket number FDA-2015-N-5017 RIN 0910-AH02. Comments can be submitted on the Regulation.gov website.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1976 states that any device presenting an “unreasonable and substantial risk of illness or injury” that cannot be, or has not been, corrected or eliminated by labeling or a change in labeling must be banned. FDA has been considering banning the use of powder on gloves since 1997 when it issued the Medical Glove Powder Report. At that time, FDA decided that the benefits of using powder with surgical and patient gloves outweighed the risks. Since then, FDA has received many citizen petitions regarding the use of glove powder.
As a reaction to the 1998 petition to review its stance on the use of powdered gloves, FDA reconsidered a ban on powdered gloves in 1999. Three main factors kept the ban from taking effect: (1) A ban would not address exposure to natural latex allergens from medical gloves with high levels of natural latex proteins; (2) a ban of powdered gloves might compromise the availability of high quality medical gloves; and (3) a ban of powdered gloves might greatly increase annual costs by almost as much as $64 million over the alternative approach proposed by FDA in the “Draft Guidance for Industry and FDA Staff: Medical Glove Guidance Manual.”
FDA is yet to finalize the ban. The Agency possibly has not received all the information regarding the risks and benefits of powdered gloves, so Nelson Laboratories, Inc. is encouraging anyone who is interested in this topic to submit comments to FDA via the link above.
