# K012969: Double Springers Nonoxnol 9 Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Medtech Products, Ltd.
- Decided: Jun 12, 2002 after 281 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Double Springers Nonoxynol 9 condom,is used for contraception and. for prophylactic purposes (to help - prevent pregpancy and the ftransmission of . sexually transmitted’ diseases).

Source page: https://510kreport.com/device/K012969
Methodology: https://510kreport.com/methodology