# K070830: Male Natural Rubber Latex Condom (with Coloring and Flavoring)

- Pathway: 510(k) (Abbreviated)
- Applicant: Karex Industries Sdn. Bhd.
- Decided: May 8, 2007 after 43 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: 4 generations back to K980964 (1999). 5 ancestors in all.
4 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)
- K041837: Innolatex Male Latex Condoms Colored and Scented, Innolatex Sdn. Bhd (2004) Summary page 1.

## Most influential descendants
- 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 Karex 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/K070830
Methodology: https://510kreport.com/methodology