# K983380: Durex Lubragel Latex Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: London Intl., LLC
- Decided: Nov 16, 1998 after 52 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: 1 generation back to K952415 (1996). 1 ancestor in all.
8 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952415: Durex, Ramses, Sheik, London International U.S. Holdings, Inc. (1996) Summary page 1.

## Most influential descendants
- K032227: Durex Flavored Latex Condom (2004), 7 descendants of its own
- 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

## Indications for use
The Durex Condom is used for contraception and for Prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Source page: https://510kreport.com/device/K983380
Methodology: https://510kreport.com/methodology