# K113061: Large/Extra Lagre Condom

- Pathway: 510(k) (Special)
- Applicant: Karex Industries Sdn. Bhd.
- Decided: Dec 7, 2011 after 54 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
No predicates in its family tree.
3 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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 Large and Extra Large condomi 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/K113061
Methodology: https://510kreport.com/methodology