# LTZ: Condom With Nonoxynol-9

- Device class: 2; regulation: 21 CFR 884.5310; FDA's rule: 510(k) required
- FDA decisions: 22
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1990: 1
- 1996: 3
- 1997: 5
- 1998: 3
- 1999: 4
- 2000: 2
- 2001: 2
- 2002: 1
- 2004: 1

## Most-cited predicates
- K952415: Durex, Ramses, Sheik (1996), cited by 3
- K974324: Latex Condoms Colour with Spermicidal Lubricant (1998), cited by 1
- K963322: Olympus,Jasmine,Jimmy-O Raincoat,Drink,Ares,Aphrodite,Zeus,Apollo,Selfcare,Careplus,Titan (1997), cited by 1
- K970791: Innerwear/Extrawear/Jimmy-O Raincoat/Zeus/Gentlemen's Choice/Jasmine/Drink/Naughty (1997), cited by 1

Source page: https://510kreport.com/product-code/LTZ
Data by year (CSV): https://510kreport.com/product-code/LTZ.csv