K-Y Brand Warming Jelly Personal Lubricant
by Personal Products Company, Div. of Mcneil-Ppc, Inc.
510(k) K040164
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040164 | Date5 Apr 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NUC
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5300
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a Personal Lubricant, classified under FDA product code NUC, designed to reduce friction and provide a warming sensation during sexual intimacy. It is a non-sterile, water-soluble, clear, and non-staining gel formulated for over-the-counter consumer use.
The lubricant is supplied as a single-use, non-reusable product and is intended for application to genital tissues. It is not MRI-safe, as no such information is provided. The device is regulated under FDA regulation number 884.5300 and holds a 510(k) clearance (K040164) with a classification of Class II. Storage conditions are not specified in the provided data.
Other devices from Personal Products Company, Div. of Mcneil-Ppc, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of this lubricant, and how does it differ from standard personal lubricants?
This lubricant, K-Y Brand Warming Jelly, is specifically designed to reduce friction *and* provide a warming sensation during sexual intimacy. Unlike standard lubricants, it includes a formulation that creates heat, which may enhance comfort and pleasure. It remains water-soluble and non-staining, ensuring ease of use and minimal residue.
Is this product intended for single-use only, and what does that mean for my purchasing needs?
Yes, this lubricant is explicitly labeled as a single-use, non-reusable product. This means each tube is meant for one application, so you’ll need to purchase multiple units for repeated use. It’s not designed to be stored or reused after opening.
Can this lubricant be used in medical settings, such as during gynecological exams or procedures?
While the product is regulated under FDA product code NUC (Non-Urological Devices) and reviewed by the Obstetrics/Gynecology Advisory Committee, it is not sterile and is classified as an over-the-counter consumer product. It is not intended for clinical or medical procedures—only for personal, at-home use during sexual intimacy.
Are there different sizes or models available, and how do I know which one to choose?
The provided data lists multiple FEI numbers, which indicate different lot or batch identifiers rather than distinct product sizes or models. Since the device is described uniformly as a single-use gel, there are no varying sizes or formulations mentioned. All tubes appear to serve the same purpose, so selection depends on personal preference for volume (e.g., standard single-serve size).
How should I store this product, and does it require refrigeration?
The data does not specify storage conditions for K-Y Brand Warming Jelly. Typically, non-sterile, water-soluble gels like this are stored at room temperature, away from direct sunlight and extreme heat. If in doubt, check the packaging label for manufacturer recommendations, as improper storage could affect texture or efficacy.