# K032227: Durex Flavored Latex Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Ssl Americas, Inc.
- Decided: Mar 29, 2004 after 252 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 K952415 (1996). 5 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020633: Natural and Colored Latex Condom with Flavors, Ls Rubber Sdn Bhd (2002) Summary page 1.
- K011253: Flavored Male Latex Condom, Thai Nippon Rubber Industry Co., Ltd. (2001) Summary page 1.
- K983380: Durex Lubragel Latex Condom, London Intl., LLC (1998) Summary page 1.

## Most influential descendants
- K081413: Twinlotus and Shields Natural Rubber Latex Condom (2008), 6 descendants of its own
- K103119: Billy Boy Male Latex Condom (2011), 5 descendants of its own
- K120394: Lifestyles Zero Lubricated Latex Condom (2012), 1 descendant of its own
- K111093: Billy Boy Male Latex Condom (2011), 1 descendant of its own
- K153016: aoni Natural Rubber Latex Condom (2016), 0 descendants of its own

## Indications for use
Durex latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

Source page: https://510kreport.com/device/K032227
Methodology: https://510kreport.com/methodology