# K081413: Twinlotus and Shields Natural Rubber Latex Condom

- Pathway: 510(k) (Traditional)
- Applicant: Dailian Latex Company, Ltd.
- Decided: Oct 24, 2008 after 157 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: 3 generations back to K952415 (1996). 6 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032227: Durex Flavored Latex Condom, Ssl Americas, Inc. (2004) Summary page 2.

## Most influential descendants
- K103119: Billy Boy Male Latex Condom (2011), 5 descendants of its own
- K120394: Lifestyles Zero Lubricated Latex Condom (2012), 1 descendant of its own
- K111093: Billy Boy Male Latex Condom (2011), 1 descendant of its own
- K153016: aoni Natural Rubber Latex Condom (2016), 0 descendants of its own
- K141256: Okamoto Studded Condom (2014), 0 descendants of its own

## Indications for use
The Twinlotus or Shield condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

Source page: https://510kreport.com/device/K081413
Methodology: https://510kreport.com/methodology