510(k) K243967

ONE Nitrile Condom by Global Protection Corp. — Product Code MOL

K243967 is an FDA 510(k) premarket notification submitted by Global Protection Corp. for the device "ONE Nitrile Condom". The FDA issued a decision of Substantially Equivalent on April 8, 2025. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Global Protection Corp. has at least 10 other 510(k) clearances on record.