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Medline Industries, Inc.s Gemini surgical instrument sterilization wrap recently received FDA 510(k) clearance for use in steam and STERRADÂ® Sterilization Systems, the company announces. With this new approval, Medline is one of the first disposable sterilization wrap manufacturers to beÂ FDA cleared for use in the three main sterilization processes: steam, ethylene oxide (ETO) and STERRADÂ® Systems low-temperature hydrogen peroxide gas plasma sterilization.
We pride ourselves on innovation and developing solutions to meet our customers needs, says Rob Lockwood, president of Medlines 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
Â Pre-Vacuum Cycles - 4 Minutes exposure at 270Â°F/132Â°C with minimum 20 minutes dry time
Â Gravity Cycle - 30 Minutes exposure at 250Â°F/121Â°C with minimum 20 minutes dry time
STERRADÂ® Sterilization Systems:
Â STERRADÂ®Â 100S System
Â STERRADÂ®Â NXÂ®System
oÂ Standard Cycle
oÂ Advanced Cycle
Â STERRADÂ®Â 100NXÂ®System
oÂ EXPRESS Cycle
oÂ Standard Cycle
oÂ FLEX Cycle
STERRADÂ® Systems are manufactured by Advanced Sterilization ProductsÂ® (ASP).
In addition to receiving this new 510(k), Medlines original 510(k) clearance for the Gemini wrap covered use in steam and ethylene oxide (ETO) processes.Â Â
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.