# K020633: Natural and Colored Latex Condom with Flavors

- Pathway: 510(k) (Abbreviated)
- Applicant: Ls Rubber Sdn Bhd
- Decided: May 15, 2002 after 77 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
Longest line of descent: 1 generation back to K980964 (1999). 1 ancestor in all.
15 later devices descend from it; 2 cite 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)
- K980964: Maxima, Trustex, Ria and Premium Condoms, Ls Rubber Sdn Bhd (1999) Summary page 1.

## Most influential descendants
- 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
- K041837: Innolatex Male Latex Condoms Colored and Scented (2004), 5 descendants of its own

## Indications for use
The condom is used for contraception and for Prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

Source page: https://510kreport.com/device/K020633
Methodology: https://510kreport.com/methodology