MEDLINE’S GEMINI STERILIZATION WRAP RECEIVES FDA 510(k) CLEARANCE FOR COMPATIBILITY WITH STEAM AND STERRAD® STERILIZATION SYSTEMS
Gemini now FDA cleared for use in all three main sterilization processes
MUNDELEIN, ILL., February 27, 2013 — Medline Industries, Inc.’s Gemini surgical instrument sterilization wrap recently received FDA 510(k) clearance for use in steam and STERRAD® Sterilization Systems, the company announced today. With this new approval, Medline is one of the first disposable sterilization wrap manufacturers to be FDA cleared for use in the three main sterilization processes: steam, ethylene oxide (ETO) and STERRAD® Systems’ low-temperature hydrogen peroxide gas plasma sterilization.
“We pride ourselves on innovation and developing solutions to meet our customers’ needs,” said Rob Lockwood, president of Medline’s Operating Room division. “As surgical sterilization technology has evolved, it is crucial our products, such as the Gemini wrap, remain compatible with all major sterilization processes used by our health care customers.”
In this new 510(k), the FDA has cleared the Gemini wrap for use in the following
- Pre-Vacuum Cycles - 4 Minutes exposure at 270°F/132°C with minimum 20 minutes dry time
- Gravity Cycle - 30 Minutes exposure at 250°F/121°C with minimum 20 minutes dry time
STERRAD® Sterilization Systems:
- STERRAD® 100S System
- STERRAD® NX®System
- o Standard Cycle
- o Advanced Cycle
- STERRAD® 100NX®System
- o EXPRESS Cycle
- o Standard Cycle
- o FLEX Cycle
STERRAD® Systems are manufactured by Advanced Sterilization Products® (ASP).
In addition to receiving this new 510(k), Medline’s original 510(k) clearance for the Gemini wrap covered use in steam and ethylene oxide (ETO) processes.
Gemini sterilization wrap, made of polypropylene SMS nonwoven fabric, is used to wrap general surgical instruments and medical devices before they are placed in a sterilization system. The wrap also maintains the sterility of the devices for 180 days. Gemini wrap is available in five different weights and a variety of sizes to fit any type of instrument.
As the nation's largest privately held manufacturer and distributor of health care and surgical products, Medline manufactures and distributes more than 350,000 products to hospitals, extended care facilities, surgery centers, physician offices, home care providers and agencies, and retailers. Recently named one of the nation’s "Best and Brightest Companies to Work for,” Medline is headquartered in Mundelein, Ill. and has more than 1,100 dedicated sales representatives nationwide to support its broad product line and cost management services.
John Marks, (847) 643-3309