NORCROSS, Ga.--(EON: Enhanced Online News)--Mölnlycke Health Care applauds the Food & Drug Administration for its final rule to ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove. The FDA stated that because powdered gloves present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling, the FDA was consequently banning those devices.1
“Banned Devices; Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove; Final Rule.”
Mölnlycke Health Care, the manufacturer of Biogel® surgical gloves, was the world’s first powder-free surgical glove manufacturer. With its release of the proprietary Biogel coating 30 years ago, it made donning surgical gloves possible without glove powder. Due to the known clinical concerns that glove powder poses for both health care workers and patients, the Biogel product line has always been exclusively powder-free. Since their introduction, Biogel gloves have continued to set the industry standard for surgical glove quality offering a wide range of sterile surgeon’s glove options for various clinical applications.
”The FDA’s ruling to ban powdered gloves is a significant positive step forward to addressing safety concerns of patients and health care workers,” said Shri Parikh, Vice President of Surgical Sales and Marketing for Mölnlycke Health Care. ”Given that the FDA has only banned one other medical device in recent history, the elimination of powdered medical gloves sends a strong statement regarding its risks.”
The FDA stated that despite posted comments requesting a 90 day to 18 month transition period, the FDA decided to make the ban effective January 18, 2017, because it determined an extension was not in the best interest of human health.
About Mölnlycke Health Care
Mölnlycke Health Care is a world-leading provider of single-use surgical and wound care products for customers, healthcare professionals and patients. We develop and bring to market innovative wound care and surgical products for use in a range of settings – from prevention through acute care to homecare. Our solutions provide value for money, supported by clinical and health economic evidence.
1 “Banned Devices; Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove; Final Rule.” 81 FR 91722 (19 December 2016), pp. 91722-91731