510(k) K220576

FAMA Male Latex Condoms by Shanghai Personage Hygiene Products Co., Ltd. — Product Code HIS

K220576 is an FDA 510(k) premarket notification submitted by Shanghai Personage Hygiene Products Co., Ltd. for the device "FAMA Male Latex Condoms". The FDA issued a decision of Substantially Equivalent on August 5, 2022. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300.