# K931220: Spermicidal Lubricated Condom

- Pathway: 510(k) (Traditional)
- Applicant: Monsys USA, Inc.
- Decided: May 22, 1996 after 1,169 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. The FDA summary names no predicate by number.

## Indications for use
Condoms, when properly used, are an effective way to prevent pregnancy, although no contraceptive can guarantee 100 % effectiveness. They will also reduce the risk of spreading sexually transmitted diseases such as AIDS, syphilis, etc.

Source page: https://510kreport.com/device/K931220
Methodology: https://510kreport.com/methodology