510(k) K994312

MALE LATEX CONDOM 56MM by Pleasure Latex Products Sdn. Bhd. — Product Code HIS

K994312 is an FDA 510(k) premarket notification submitted by Pleasure Latex Products Sdn. Bhd. for the device "MALE LATEX CONDOM 56MM". The FDA issued a decision of Substantially Equivalent on March 21, 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.