# 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

- Pathway: 510(k) (Traditional)
- Applicant: Ttk Healthcare Limited
- Decided: Sep 7, 2023 after 244 days
- Product code: HIS (Condom)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K822088 (1982). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211152: Durex Condom with Benzocaine, Rb Health (Us), LLC (2022) Summary page 4.

## Indications for use
SKORE Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Source page: https://510kreport.com/device/K230049
Methodology: https://510kreport.com/methodology