UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer
FDA 510(k) K143529 · Medline Industries, Inc.
510(k) numberK143529
Submission
- Device name
- UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- December 12, 2014
- Decision date
- August 21, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUC – Lubricant, Personal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
This device 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 may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.
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Questions and answers
When was UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer cleared by the FDA?
UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer (K143529) received a 510(k) decision of Substantially Equivalent on August 21, 2015, 252 days after the submission was received.
What is the product code of K143529?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.