# K042957: Durex Male Latex Condom with Warming Lubricant

- Pathway: 510(k) (Abbreviated)
- Applicant: Ssl Americas
- Decided: Feb 17, 2005 after 113 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 K980319 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980319: Durex Ultra Comfort, London Intl., LLC (1998) Summary page 1.
- K021492: K-Y Brand Warming Liquid Personal Lubricant, Personal Products Co., Div. of Mcneil Ppc, Inc. (2002) Summary page 1.
- (no number) Trojan Shared Pleasure condom: named in the summary without a submission number

## Most influential descendants
- K051273: Divas Dual Pleasure Male Latex Condom (2005), 0 descendants of its own

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

Source page: https://510kreport.com/device/K042957
Methodology: https://510kreport.com/methodology