510(k) K212198

Tyvek(R) Roll with CI for STERLINKTM Sterilizer by Plasmapp Co,., Ltd. — Product Code FRG

K212198 is an FDA 510(k) premarket notification submitted by Plasmapp Co,., Ltd. for the device "Tyvek(R) Roll with CI for STERLINKTM Sterilizer". The FDA issued a decision of Substantially Equivalent on October 22, 2021. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Plasmapp Co,., Ltd. has at least 7 other 510(k) clearances on record.