510(k) K012964

56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM by Innolatex Sdn. Bhd — Product Code HIS

K012964 is an FDA 510(k) premarket notification submitted by Innolatex Sdn. Bhd for the device "56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM". The FDA issued a decision of Substantially Equivalent on November 9, 2001. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Innolatex Sdn. Bhd has at least 8 other 510(k) clearances on record.