# K221906: TROJAN Fire & Ice lubricated male natural rubber latex condom

- Pathway: 510(k) (Traditional)
- Applicant: Church & Dwight Co., Inc.
- Decided: Sep 28, 2022 after 90 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 K912901 (1992). 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)
- K131887: Trojan Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant, Church & Dwight Co., Inc. (2013) Summary page 4.

## Indications for use
The TROJANTm Fire & Ice male natural rubber latex condom with lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).

Source page: https://510kreport.com/device/K221906
Methodology: https://510kreport.com/methodology