510(k) K243584

0.04 ZERO ZERO FOUR Male Latex Condom by Okamoto USA, Inc. — Product Code HIS

K243584 is an FDA 510(k) premarket notification submitted by Okamoto USA, Inc. for the device "0.04 ZERO ZERO FOUR Male Latex Condom". The FDA issued a decision of Substantially Equivalent on February 18, 2025. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Okamoto USA, Inc. has at least 10 other 510(k) clearances on record.