510(k) K193578

Non-spermicidal Lubricated Male Latex Condom by Global Protection Corp. — Product Code HIS

K193578 is an FDA 510(k) premarket notification submitted by Global Protection Corp. for the device "Non-spermicidal Lubricated Male Latex Condom". The FDA issued a decision of Substantially Equivalent on August 20, 2020. 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.