Poise Personal Lubricant
FDA 510(k) K120650 · Kimberly-Clark Corporation
510(k) numberK120650
Submission
- Device name
- Poise Personal Lubricant
- Applicant
- Kimberly-Clark Corporation
Roswell, GA, US - Received
- March 2, 2012
- Decision date
- July 11, 2012
- 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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| 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 |
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| 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 |
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| K140963 | Kimguard Smart-Fold Sterilization WrapFRG · Traditional | 11/10/2014SE |
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| K140539 | Aero Blue Performance Surgical GownFYA · Abbreviated | 06/09/2014SE |
Questions and answers
When was Poise Personal Lubricant cleared by the FDA?
Poise Personal Lubricant (K120650) received a 510(k) decision of Substantially Equivalent on July 11, 2012, 131 days after the submission was received.
What is the product code of K120650?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.