510(k) K010371

LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT by Suretex, Ltd. — Product Code HIS

K010371 is an FDA 510(k) premarket notification submitted by Suretex, Ltd. for the device "LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT". The FDA issued a decision of Substantially Equivalent on Apr 27, 2001. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Suretex, Ltd. has 4 other 510(k) clearances on record.