# K010919: Male Natural Rubber Latex Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Innolatex Sdn. Bhd
- Decided: Jun 15, 2001 after 80 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K010919
Methodology: https://510kreport.com/methodology