# K981955: Maxima, Trustex, Ria and Premium EL Les Condoms

- Pathway: 510(k) (Traditional)
- Applicant: Ls Rubber Sdn Bhd
- Decided: Mar 15, 1999 after 284 days
- Product code: LTZ (Condom With Nonoxynol-9)
- Device class: 2
- Regulation: 21 CFR 884.5310
- 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 intended use of these latex coloured condoms with spermicidal lubricant is for contraception and prophylactics purposes (preventing transmission of venereal diseases.)

Source page: https://510kreport.com/device/K981955
Methodology: https://510kreport.com/methodology