# K213547: SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla

- Pathway: 510(k) (Special)
- Applicant: Ttk Healthcare Limited
- Decided: Dec 23, 2021 after 45 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: 2 generations back to K132490 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202403: SKORE (Colors & Flavors), SKORE (Colors), Ttk Healthcare Limited (2021) Summary page 4.

## Indications for use
SKORE Vanilla, SKORE Strawberry, SKORE Banana, SKORE Chocolate, and SKORE Tangerine Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Source page: https://510kreport.com/device/K213547
Methodology: https://510kreport.com/methodology