510(k) K021875

MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM by Pleasure Latex Products Sdn. Bhd. — Product Code HIS

K021875 is an FDA 510(k) premarket notification submitted by Pleasure Latex Products Sdn. Bhd. for the device "MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM". The FDA issued a decision of Substantially Equivalent on September 5, 2002. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Pleasure Latex Products Sdn. Bhd. has at least 9 other 510(k) clearances on record.