510(k) K241036

Autoclave Indicator Tape; EO Indicator Tape by Jiangmen New Era External Use Drug Co., Ltd. — Product Code JOJ

K241036 is an FDA 510(k) premarket notification submitted by Jiangmen New Era External Use Drug Co., Ltd. for the device "Autoclave Indicator Tape; EO Indicator Tape". The FDA issued a decision of Substantially Equivalent on December 17, 2024. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800.