# K942858: Latex Condoms W/Spermicidal Lubricant (Nonoxynol-9)

- Pathway: 510(k) (Traditional)
- Applicant: Suretex, Ltd.
- Decided: May 18, 1995 after 428 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.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K983320: Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted Colors (1998), 3 descendants of its own
- K030176: Lifestyles, Contempo or Private Label-Male Latex Condom with Desensitizing Lubricant (2003), 1 descendant of its own
- K033541: Long Love Condom (2003), 0 descendants of its own
- K992081: Various Ansell Tradenames or Private Label (1999), 0 descendants of its own
- K981621: Royale of Latex Condoms - Spermicidal Lubricant - Colored or Assorted Colors (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K942858
Methodology: https://510kreport.com/methodology