510(k) K041837

INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED by Innolatex Sdn. Bhd — Product Code HIS

K041837 is an FDA 510(k) premarket notification submitted by Innolatex Sdn. Bhd for the device "INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED". The FDA issued a decision of Substantially Equivalent on September 24, 2004. 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.