510(k) K242898

Sterilization Pouches and Reels by Shanghai Jianzhong Medical Packaging Co., Ltd. — Product Code FRG

K242898 is an FDA 510(k) premarket notification submitted by Shanghai Jianzhong Medical Packaging Co., Ltd. for the device "Sterilization Pouches and Reels". The FDA issued a decision of Substantially Equivalent on February 21, 2025. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Shanghai Jianzhong Medical Packaging Co., Ltd. has at least 2 other 510(k) clearances on record.