# K972428: Extrawear, Gentlemen's Choice

- Pathway: 510(k) (Traditional)
- Applicant: Custom Services Intl., Inc.
- Decided: Aug 25, 1997 after 59 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 K970767 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970767: Condom (Rubber), Lubricated, Extra Strength, Custom Services Intl., Inc. (1997) Summary page 1.
- K970792: Innerwear/Extrawear/Jimmy-O Raincoat/Zeus/Gentlemen's Choice, Titan Condoms (1997) Summary page 1.

## Indications for use
Extra Strength lubricated rubber male condom 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.” Extra strength nonlubricated rubber male condom 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.”

Source page: https://510kreport.com/device/K972428
Methodology: https://510kreport.com/methodology