About This 510(k) Submission
K230049 is an FDA 510(k) clearance for the 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, a Condom (Class II — Special Controls, product code HIS), submitted by Ttk Healthcare Limited (Puducherry, IN). The FDA issued a Cleared decision on September 7, 2023, 244 days after receiving the submission on January 6, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.