# K970767: Condom (Rubber), Lubricated, Extra Strength

- Pathway: 510(k) (Traditional)
- Applicant: Custom Services Intl., Inc.
- Decided: Jun 2, 1997 after 91 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
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
- K972428: Extrawear, Gentlemen's Choice (1997), 0 descendants of its own

## Indications for use
Extra Strength lubricated rubber male condom for use as a contraceptive and prophylactic.

Source page: https://510kreport.com/device/K970767
Methodology: https://510kreport.com/methodology