# K994095: Latex Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Thai Nippon Rubber Industry Co., Ltd.
- Decided: Jan 18, 2000 after 46 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 K941258 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941258: Latex Condom, Suretex, Ltd. (1995) Summary page 1.

## Most influential descendants
- K012653: Male Latex Condom (2001), 0 descendants of its own

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

Source page: https://510kreport.com/device/K994095
Methodology: https://510kreport.com/methodology