# K141059: Natural Rubber Latex Male Condoms

- Pathway: 510(k) (Abbreviated)
- Applicant: Karex Industries Sdn. Bhd.
- Decided: Aug 1, 2014 after 99 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Natural Rubber Latex Male Condoms [Parallel Sided, Smooth, Lubricated or Non-lubricated] a) Parallel Sided Smooth, 53mm Condoms b) Parallel Sided Smooth, 53mm Condoms — Ultra Thin c) Parallel Sided Smooth, 53mm Condoms — Super Thin d) Parallel Sided Smooth, 56mm Condoms e) Parallel Sided Smooth, 56mm Condoms — Ultra Thin The Karex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Source page: https://510kreport.com/device/K141059
Methodology: https://510kreport.com/methodology