# K041837: Innolatex Male Latex Condoms Colored and Scented

- Pathway: 510(k) (Abbreviated)
- Applicant: Innolatex Sdn. Bhd
- Decided: Sep 24, 2004 after 79 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: 3 generations back to K980964 (1999). 4 ancestors in all.
5 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)
- K011253: Flavored Male Latex Condom, Thai Nippon Rubber Industry Co., Ltd. (2001) Summary page 1.
- K023175: Unidus Male Latex Condom (with Color and Flavoring), Unidus Corp. (2002) Summary page 1.

## Most influential descendants
- K070830: Male Natural Rubber Latex Condom (with Coloring and Flavoring) (2007), 4 descendants of its own
- K081886: Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated and Non Lubricated (2009), 3 descendants of its own
- K122219: Theyfit Male Condom (2013), 2 descendants of its own
- K210208: Titan Condoms (2022), 0 descendants of its own
- K150072: TheyFit Male Condom (2015), 0 descendants of its own

## Indications for use
The Innolatex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Source page: https://510kreport.com/device/K041837
Methodology: https://510kreport.com/methodology