Carex Hybrid Personal Lubricant
FDA 510(k) K223519 · Karex Industries Sdn. Bhd.
510(k) numberK223519
Submission
- Device name
- Carex Hybrid Personal Lubricant
- Applicant
- Karex Industries Sdn. Bhd.
Pontian, MY - Received
- November 23, 2022
- Decision date
- August 11, 2023
- 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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|---|---|---|---|
| K253989 | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based…NUC · Traditional | Maxigen Biotech, Inc. | 09/03/2026SE |
| 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 |
|---|---|---|
| K150743 | Water Based Personal Lubricant with FlavoursNUC · Abbreviated | 11/12/2015SE |
| 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 Carex Hybrid Personal Lubricant cleared by the FDA?
Carex Hybrid Personal Lubricant (K223519) received a 510(k) decision of Substantially Equivalent on August 11, 2023, 261 days after the submission was received.
What is the product code of K223519?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.