# K042958: Durex Play Tingling Lubricant

- Pathway: 510(k) (Abbreviated)
- Applicant: Ssl Americas, Inc.
- Decided: Apr 8, 2005 after 163 days
- Product code: NUC (Lubricant, Personal)
- 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
Longest line of descent: 3 generations back to K810310 (1981). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955648: K-Y Personal Lubricant, Ortho Pharmaceutical Corp. (1996) Summary page 1.
- K935299: Astroglide, Biofilm, Inc. (1994) Summary page 1.
- K900679: Mint Scented Condoms, Schmid Laboratories, Inc. (1990) Summary page 1.
- K032124: Durex Play Lubricant, Ssl Americas, Inc. (2004) Summary page 1.

## Indications for use
Durex Play TM Tingling Lubricant is intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.

Source page: https://510kreport.com/device/K042958
Methodology: https://510kreport.com/methodology