Adhesive Bandage Receives FDA Clearance
This new bandage clearance reportedly expands the company's label to include the management of moderately to heavily exuding chronic wounds and acute wounds.
gel-e Inc. recently announced the 510(k) clearance of its adhesive bandage by the U.S. Food and Drug Administration for prescription and over-the-counter use. This new bandage clearance reportedly expands the company's label to include the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision, the bandage can be used for the management of pressure sores, diabetic ulcers, leg ulcers, donor sites and graft sites, surgical wounds, skin abrasions and lacerations, first- and second-degree burns, and traumatic wounds.
"This clearance is the next step in expanding our external wound product line, and will be a key component of gel-e's 21st Century First Aid Kit™," said Elsa Abruzzo, head of regulatory. "We are developing a tool kit for clinicians and caregivers that will provide the best possible options for all manner of chronic and acute wounds and injuries. This bandage represents just the first tool in the kit."
For more information, visit www.gel-e.co.