510(k) K213921

Microthin Natural Rubber Latex Condom by Suretex Limited — Product Code HIS

K213921 is an FDA 510(k) premarket notification submitted by Suretex Limited for the device "Microthin Natural Rubber Latex Condom". The FDA issued a decision of Substantially Equivalent on April 28, 2022. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Suretex Limited has at least 5 other 510(k) clearances on record.