# K970791: Innerwear/Extrawear/Jimmy-O Raincoat/Zeus/Gentlemen's Choice/Jasmine/Drink/Naughty

- Pathway: 510(k) (Traditional)
- Applicant: Custom Services Intl., Inc.
- Decided: Jun 3, 1997 after 91 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K972430: Extrawear, Gentlemen's Choice W/Nonoxynol-9 (1997), 0 descendants of its own

## Indications for use
Extra strength lubricated rubrer male condom with Nonoxynol-9 for use as a contraceptive and prophylactic. Additional Statement: “Labdratory 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 dondom contains a latex condom and 8 spermicidal lubricant. The spermicide, Nonoxyno!-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if you lose your efection 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 sas a substitute er the combined use of a vaginal spermicide and a condom

Source page: https://510kreport.com/device/K970791
Methodology: https://510kreport.com/methodology