510(k) K024324

LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9 by Global Protection Corp. — Product Code HIS

K024324 is an FDA 510(k) premarket notification submitted by Global Protection Corp. for the device "LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9". The FDA issued a decision of Substantially Equivalent on March 25, 2003. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Global Protection Corp. has at least 10 other 510(k) clearances on record.