510(k) K230049

SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT by Ttk Healthcare Limited — Product Code HIS

K230049 is an FDA 510(k) premarket notification submitted by Ttk Healthcare Limited for the device "SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT". The FDA issued a decision of Substantially Equivalent on September 7, 2023. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Ttk Healthcare Limited has at least 2 other 510(k) clearances on record.