510(k) K023333

MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR by Pleasure Latex Products Sdn. Bhd. — Product Code HIS

K023333 is an FDA 510(k) premarket notification submitted by Pleasure Latex Products Sdn. Bhd. for the device "MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR". The FDA issued a decision of Substantially Equivalent on June 23, 2003. 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.