Astroglide Ultra Gentle Gel
FDA 510(k) K220355 · Biofilm, Inc.
510(k) numberK220355
Submission
- Device name
- Astroglide Ultra Gentle Gel
- Applicant
- Biofilm, Inc.
Vista, CA, US - Received
- February 8, 2022
- Decision date
- May 26, 2022
- 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.
Other 510(k)s with product code NUC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K221036 | Astroglide WarmingNUC · Traditional | 07/01/2022SE |
| K220653 | Astroglide Glycerin & Paraben FreeNUC · Traditional | 05/06/2022SE |
| K213671 | Astroglide Sensual Strawberry Personal LubricantNUC · Traditional | 03/03/2022SE |
| K210242 | Astroglide X Silicone Personal LubricantNUC · Traditional | 04/28/2021SE |
| K200239 | Astroglide Organix GelNUC · Traditional | 11/13/2020SE |
| K200114 | Astroglide Organix LiquidNUC · Traditional | 10/13/2020SE |
| K171985 | Astroglide O Oil Personal Lubricant & Massage OilNUC · Traditional | 08/30/2017SE |
| K163395 | Astroglide Diamond Silicone Gel Personal LubricantNUC · Traditional | 02/10/2017SE |
| K141132 | Astroglide TTC Fertility Friendly Personal LubricantPEB · Traditional | 01/09/2015SE |
| K140590 | Astroglide Sensual StrawberryNUC · Traditional | 10/30/2014SE |
Questions and answers
When was Astroglide Ultra Gentle Gel cleared by the FDA?
Astroglide Ultra Gentle Gel (K220355) received a 510(k) decision of Substantially Equivalent on May 26, 2022, 107 days after the submission was received.
What is the product code of K220355?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.