510(k) K081886

KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED by Karex Industries Sdn. Bhd. — Product Code HIS

K081886 is an FDA 510(k) premarket notification submitted by Karex Industries Sdn. Bhd. for the device "KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED". The FDA issued a decision of Substantially Equivalent on February 6, 2009. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Karex Industries Sdn. Bhd. has at least 7 other 510(k) clearances on record.