510(k) K001221

MALE LATEX COMDOM WITH DOTTED SURFACE by Pleasure Latex Products Sdn. Bhd. — Product Code HIS

K001221 is an FDA 510(k) premarket notification submitted by Pleasure Latex Products Sdn. Bhd. for the device "MALE LATEX COMDOM WITH DOTTED SURFACE". The FDA issued a decision of Substantially Equivalent on May 19, 2000. 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.