510(k) K252622

Male Latex Condom HA by Okamoto USA, Inc. — Product Code HIS

K252622 is an FDA 510(k) premarket notification submitted by Okamoto USA, Inc. for the device "Male Latex Condom HA". The FDA issued a decision of Substantially Equivalent on May 4, 2026. 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.