Water Based Personal Lubricant with Flavours
FDA 510(k) K150743 · Karex Industries Sdn. Bhd.
510(k) numberK150743
Submission
- Device name
- Water Based Personal Lubricant with Flavours
- Applicant
- Karex Industries Sdn. Bhd.
Pontian, MY - Received
- March 23, 2015
- Decision date
- November 12, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement 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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| K261905 | BUM OilNUC · Traditional | Bumlicious, LLC (DBA Bumlicious) | 08/07/2026SE |
| K261177 | PINKSLIP Water-Based Personal Lubricant and MoisturizerNUC · Traditional | Pinkslip, LLC | 07/09/2026SE |
| K261909 | Plum Vagiceuticals Vaginal Moisturizing SuppositoriesNUC · Traditional | PCCA, Inc. | 07/06/2026SE |
| K254011 | Flow Water-Based Personal LubricantNUC · Traditional | LBDO Group, Inc. | 06/22/2026SE |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)NUC · Traditional | PR Personal Care Laboratories | 06/11/2026SE |
| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)NUC · Traditional | Hathor Professional Skincare , Ltd. | 06/09/2026SE |
| K260068 | pjur NATURE Touch, 100 mlNUC · Traditional | Pjur Group Luxembourg S.A. | 05/21/2026SE |
| K254101 | Julva Velvé Water-Based Personal LubricantNUC · Traditional | Golden Isles Medical, Inc. | 04/16/2026SE |
| K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA…NUC · Traditional | Hudi Pharma Srl | 04/01/2026SE |
More from Hudi Pharma Srl
| 510(k) | Device | Decision |
|---|---|---|
| K223519 | Carex Hybrid Personal LubricantNUC · Abbreviated | 08/11/2023SE |
| K141059 | Natural Rubber Latex Male CondomsHIS · Abbreviated | 08/01/2014SE |
| K132597 | Black Coloured CondomHIS · Abbreviated | 11/25/2013SE |
| K113056 | Orange Colored Condoms Orange ScentHIS · Special | 07/03/2012SE |
| K113061 | Large/Extra Lagre CondomHIS · Special | 12/07/2011SE |
| K081886 | Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated and Non…HIS · Abbreviated | 02/06/2009SE |
| K070830 | Male Natural Rubber Latex Condom (with Coloring and Flavoring)HIS · Abbreviated | 05/08/2007SE |
Questions and answers
When was Water Based Personal Lubricant with Flavours cleared by the FDA?
Water Based Personal Lubricant with Flavours (K150743) received a 510(k) decision of Substantially Equivalent on November 12, 2015, 234 days after the submission was received.
What is the product code of K150743?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.