Cardinal Health announces Food and Drug Administration (FDA) clearance (K120542) for use of its DuraBlue Sterilization Wrap with Ethylene Oxide sterilizers.
"This clearance is an affirmation of our commitment to creating solutions for our customers diverse needs, to continuous contributions that can help improve the efficiency of the healthcare system, and to regulatory compliance," says Greg Groenke, general manager of environmental technologies at Cardinal Health."
Cardinal Health DuraBlue Sterilization Wrap previously received FDA clearances for use with the following sterilization modalities:
Pre-Vacuum Steam Sterilization at 270 degrees Fahrenheit for four minutes (K112211)
Johnson and Johnson STERRAD® 100S (K112283)
Lumen, Non-Lumen and Flexible Cycles in the Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus, and Amsco® V-PRO® maX Low Temperature Sterilization Systems (K112918)
Sterilization wrap is critical for the productive use of reusable surgical instruments, as it enables the effective sterilization of medical devices contained in instrument trays and maintains their sterility. The new Cardinal Health DuraBlue Sterilization Wrap can help bring efficiencies to the sterilization process while maintaining a high standard of aseptic technique. Its double-layer construction enables users to save time by using the simultaneous wrapping technique, eliminating the need for double wrapping with single-layer wrap.
DuraBlue Sterilization Wrap is made with non-woven, polypropylene SMS technology for strength, durability and microbial protection. DuraBlue Sterilization Wrap is available in six color-coded basis weight models, providing durable protection for everything from lightweight linen packs to heavy instrument trays weighing up to 25 pounds. The wrap also is available in 14 sizes ranging from 12 inches by 12 inches to 54 inches by 90 inches.