# K210294: One Touch Spiral Condom

- Pathway: 510(k) (Traditional)
- Applicant: Thai Nippon Rubber Industry Public Company Limited.
- Decided: Sep 23, 2021 after 233 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K243421: Lelo Hex Lubricated Natural Rubber Latex Condom (2025), 0 descendants of its own

## Indications for use
The One Touch Spiral Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Source page: https://510kreport.com/device/K210294
Methodology: https://510kreport.com/methodology