# K972427: Innerwear, Jimmy-O Raincoat, Raincoat, Jasmine, Drink

- Pathway: 510(k) (Traditional)
- Applicant: Custom Services Intl., Inc.
- Decided: Aug 20, 1997 after 54 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 K901112 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963319: Olympus,Jasmine,Jimmy-O Raincoat,Drink,Ares,Aphrodit,Zeus,Apollo,Selfcare,Careplus,Titan, Custom Services Intl., Inc. (1997) Summary page 1.
- K963321: Olympus,Jasmine,Jimmy-O Raincoat,Drink,Ares,Aphrodite,Zeus,Apollo,Selfcare,Careplus,Titan, Custom Services Intl., Inc. (1997) Summary page 1.
- K901112: G.S.a. Colored Condoms, Ansell, Inc. (1990) Summary page 1.

## Indications for use
Nonlubricated rubber male condom for use as a contraceptive and prophylactic.

Source page: https://510kreport.com/device/K972427
Methodology: https://510kreport.com/methodology