# K132597: Black Coloured Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Karex Industries Sdn. Bhd.
- Decided: Nov 25, 2013 after 98 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
Black Colored Condoms [Parallel Sided or Contoured or Flared, Textured or Non-textured, Lubricated or Non-lubricated] a) Parallel sided smooth, 53mmr Black colored condom b) Parallel sided dotted, 53mm Black colored condom c) Parallel sided ribbed, 53mm Black colored condom d) Parallel sided smooth, 56mm Black colored condom e) Contoured studded, 53mm Black colored condom f) Contoured ribbed & studded, 53mm Black colored condom g) Contoured ribbed, 52mm Black colored condom h) Flared smooth, 56mm Black colored condom 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/K132597
Methodology: https://510kreport.com/methodology