510(k) K213907

CareGUARD Sterilization Wrap by Care Essentials Pty, Ltd. — Product Code FRG

K213907 is an FDA 510(k) premarket notification submitted by Care Essentials Pty, Ltd. for the device "CareGUARD Sterilization Wrap". The FDA issued a decision of Substantially Equivalent on March 14, 2022. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Care Essentials Pty, Ltd. has at least 3 other 510(k) clearances on record.