# K143529: UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Aug 21, 2015 after 252 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: 1 generation back to K020827 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020827: K-Y Brand Ultra Gel Personal Lubricant, Personal Products Co., Div. of Mcneil Ppc, Inc. (2002) Summary page 4.

## Indications for use
Ultrasmooth Lubricating Liquid is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. Medline Lubricating Liquid and Vaginal Moisturizer is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms.

Source page: https://510kreport.com/device/K143529
Methodology: https://510kreport.com/methodology