# K092586: Male Latex Condom (Straight Side or Contoured or Flared in Shape, Either Textured or Non-Textured , Lubricated or Non-LU

- Pathway: 510(k) (Abbreviated)
- Applicant: Innolatex (Thailand) Limited
- Decided: May 12, 2010 after 261 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
The Innolatex condom used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

Source page: https://510kreport.com/device/K092586
Methodology: https://510kreport.com/methodology