510(k) K242839

Safe Secure Sterilization Pouches and Rolls by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. — Product Code FRG

K242839 is an FDA 510(k) premarket notification submitted by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. for the device "Safe Secure Sterilization Pouches and Rolls". The FDA issued a decision of Substantially Equivalent on October 16, 2024. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. has at least 2 other 510(k) clearances on record.