# K000408: Lifestyles, Contempo or Private Label Strawberry, Vanilla, or Banana Flavored Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Suretex Prophylactics, Ltd.
- Decided: Apr 19, 2000 after 71 days
- Product code: HIS (Condom)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: 2 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 5, 2012 · Class II · Z-0717-2013: One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.
- Nov 25, 2002 · Not classified · Z-0402-03: The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards

Source page: https://510kreport.com/device/K000408
Methodology: https://510kreport.com/methodology