# K063401: Banana Ribbed

- Pathway: 510(k) (Abbreviated)
- Applicant: Medtech Products, Ltd.
- Decided: Mar 26, 2007 after 137 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Life styles Snugger fit condom: named in the summary without a submission number
- (no number) Durex love condom: named in the summary without a submission number
- (no number) Trojan extended pleasure: named in the summary without a submission number

## Indications for use
The BANANA Ribbed condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

Source page: https://510kreport.com/device/K063401
Methodology: https://510kreport.com/methodology