# K980964: Maxima, Trustex, Ria and Premium Condoms

- Pathway: 510(k) (Traditional)
- Applicant: Ls Rubber Sdn Bhd
- Decided: Mar 12, 1999 after 361 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.
16 later devices descend from it; 1 cites it directly.
0 of 17 devices 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.

## Most influential descendants
- K020633: Natural and Colored Latex Condom with Flavors (2002), 15 descendants of its own
- K032227: Durex Flavored Latex Condom (2004), 7 descendants of its own
- K081413: Twinlotus and Shields Natural Rubber Latex Condom (2008), 6 descendants of its own
- K023175: Unidus Male Latex Condom (with Color and Flavoring) (2002), 6 descendants of its own
- K103119: Billy Boy Male Latex Condom (2011), 5 descendants of its own

## Indications for use
The intended use of these latex coloured condoms with flavour lubricant is for contraception and prophylactics purposes (preventing transmission of venereal diseases.)

Source page: https://510kreport.com/device/K980964
Methodology: https://510kreport.com/methodology