# K081265: Thai Nippon Male Latex Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Thai Nippon Rubber Industry Co., Ltd.
- Decided: Oct 16, 2009 after 529 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 K001212 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001212: Trojan Extra Large Latex Condom, Armkel, LLC (2000) Summary page 1.

## Indications for use
The Thai Nippon Male Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

Source page: https://510kreport.com/device/K081265
Methodology: https://510kreport.com/methodology