# K020659: Durex Latex Condom with Male Genital Desensitizer Lubricant

- Pathway: 510(k) (Special)
- Applicant: Ssl Americas, Inc.
- Decided: Mar 29, 2002 after 28 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 K822088 (1982). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 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.
- K822088: Male Condom, Schmid Laboratories, Inc. (1982) Summary page 1.

## Most influential descendants
- K211152: Durex Condom with Benzocaine (2022), 1 descendant of its own
- K230049: SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT (2023), 0 descendants of its own

## Indications for use
The DUREX® Latex Condom with Male Genital Desensitizer Lubricant is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases. The male genital desensitizer lubricant on the condom helps in temporarily prolonging the time until ejaculation.

Source page: https://510kreport.com/device/K020659
Methodology: https://510kreport.com/methodology