# K972430: Extrawear, Gentlemen's Choice W/Nonoxynol-9

- Pathway: 510(k) (Traditional)
- Applicant: Custom Services Intl., Inc.
- Decided: Sep 10, 1997 after 75 days
- Product code: LTZ (Condom With Nonoxynol-9)
- Device class: 2
- Regulation: 21 CFR 884.5310
- 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 K970791 (1997). 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)
- K970791: Innerwear/Extrawear/Jimmy-O Raincoat/Zeus/Gentlemen's Choice/Jasmine/Drink/Naughty, Custom Services Intl., Inc. (1997) Summary page 1.

## Indications for use
Extra strength lubricated rubber male condom with Nonoxynol-9 for use as a contraceptive and prophylactic. Additional Statement: “Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested.” Additional Statement: This condom contains a latex condom and a spermicidal lubricant. The spermicide, Nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if you lose your erection before withdrawal and some semen spill outside the condom. However the extent of the decreased risk has not been established. This condom should not be used as a substitute for the combined use of a vaginal spermicide and a condom

Source page: https://510kreport.com/device/K972430
Methodology: https://510kreport.com/methodology