Astroglide Ultra Gentle Gel
FDA 510(k)Class II (US FDA 510(k))
by Biofilm, Inc
Identifiers
- 510(k) Number
- K220355 FDA 510(k)
- FDA Product Code
- NUC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5300 FDA 510(k)
- Regulation Number
- 884.5300 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Astroglide Ultra Gentle Gel is a personal lubricant intended for penile, vaginal, and/or anal application to moisturize and lubricate, enhancing the ease and comfort of intimate sexual activity and supplementing the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms.
The Astroglide Ultra Gentle Gel is a Class II medical device with product code NUC, cleared by the FDA under 510(k) K220355 on May 26, 2022. It is manufactured by Biofilm, Inc. in Vista, CA, and is regulated under moderate risk with special controls for Obstetrics/Gynecology. The device is supplied as a gel formulation and is intended for personal use.
Frequently asked questions
What is Astroglide Ultra Gentle Gel used for?
Astroglide Ultra Gentle Gel is a personal lubricant intended for penile, vaginal, and/or anal application to moisturize and lubricate, enhancing the ease and comfort of intimate sexual activity and supplementing the body's natural lubrication.
Is Astroglide Ultra Gentle Gel compatible with condoms?
Yes, Astroglide Ultra Gentle Gel is compatible with natural rubber latex and polyisoprene condoms, making it safe for use with barrier protection methods.
What is the regulatory status of Astroglide Ultra Gentle Gel?
Astroglide Ultra Gentle Gel is a Class II medical device with product code NUC, cleared by the FDA under 510(k) K220355 on May 26, 2022. It is manufactured by Biofilm, Inc. in Vista, CA.
How is Astroglide Ultra Gentle Gel supplied?
The device is supplied as a gel formulation and is intended for personal use. It is regulated under moderate risk with special controls for Obstetrics/Gynecology.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Astroglide Ultra Gentle Gel — FDA Class II Medical Device | MedEquip ..., Astroglide Ultra Gentle Gel (K220355) — FDA 510(k) | Innolitics, K220355 FDA 510(k) - Astroglide Ultra Gentle Gel | Biofilm, Inc., Astroglide Ultra Gentle Gel — FDA Class II Medical Device | MedEquip ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220355 | Class II | Active |
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Manufacturer
- Manufacturer
- Biofilm, Inc
- FDA Applicant
- Biofilm, Inc.
Sources (1)
- FDA 510(k) K220355 24 fields · synced Sep 27, 2026