# K063385: Durex Play Massage Gel Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Ssl Americas, Inc.
- Decided: Mar 10, 2008 after 488 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.
- K042563: Durex Play Warmer Lubricant, Ssl Americas, Inc. (2005) Summary page 1.
- K032124: Durex Play Lubricant, Ssl Americas, Inc. (2004) Summary page 1.

## Indications for use
Durex PlayTMMassage gel 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. This lubricant has been shown to be compatible only with condoms made of natural rubber latex and synthetic polyisoprene.

Source page: https://510kreport.com/device/K063385
Methodology: https://510kreport.com/methodology