# K081886: Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated and Non Lubricated

- Pathway: 510(k) (Abbreviated)
- Applicant: Karex Industries Sdn. Bhd.
- Decided: Feb 6, 2009 after 219 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: 5 generations back to K980964 (1999). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012962: Dotted Condom, Male Natural Rubber Latex Condom, Innolatex Sdn. Bhd (2001) Summary page 1.
- K010919: Male Natural Rubber Latex Condom, Innolatex Sdn. Bhd (2001) Summary page 1.
- K053367: Male Natural Rubber Latex Condom, Innolatex Sdn. Bhd (2006) Summary page 1.
- K070830: Male Natural Rubber Latex Condom (with Coloring and Flavoring), Karex Industries Sdn. Bhd. (2007) Summary page 1.
- K002060: Natural Ordinary Ribbed,Dotted,and Contoured (Male Rubber Latex Condom, Lubricated W/Silicone Oil, Dongkuk Techco Rubber Industries (2000) Summary page 1.

## Most influential descendants
- 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/K081886
Methodology: https://510kreport.com/methodology