# K011253: Flavored Male Latex Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Thai Nippon Rubber Industry Co., Ltd.
- Decided: Jul 20, 2001 after 87 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.
14 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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
- 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
- K070830: Male Natural Rubber Latex Condom (with Coloring and Flavoring) (2007), 4 descendants of its own

Source page: https://510kreport.com/device/K011253
Methodology: https://510kreport.com/methodology