# K161195: Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)

- Pathway: 510(k) (Abbreviated)
- Applicant: M3 Global Enterprises, LLC
- Decided: Aug 25, 2016 after 120 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 K897129 (1990). 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)
- K071313: Trojan-Enz Brand, Church & Dwight Co., Inc. (2007) Summary page 4.

## Indications for use
The Royal Condoms are used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Source page: https://510kreport.com/device/K161195
Methodology: https://510kreport.com/methodology