Astroglide Glycerin & Paraben Free
FDA 510(k)Class II (US FDA 510(k))
by Biofilm, Inc
Identifiers
- 510(k) Number
- K220653 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 Glycerin & Paraben Free is a personal lubricant classified under device class 2 with the product code NUC. It is intended for penile, anal, or vaginal application to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.
The device is supplied as a non-sterile, single-use product and is regulated under FDA 510(k) clearance K220653, which was granted as substantially equivalent on May 6, 2022. It is manufactured by Biofilm, Inc. and is intended for use in obstetrics/gynecology settings as indicated by the advisory committee classification.
Frequently asked questions
What is Astroglide Glycerin & Paraben Free intended for?
It is intended for penile, anal, or vaginal application to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.
How is Astroglide Glycerin & Paraben Free supplied and is it sterile or single-use?
The device is supplied as a non-sterile, single-use product, meaning it is not sterilized and is designed for one-time use only to reduce contamination risk.
What regulatory pathway was used for Astroglide Glycerin & Paraben Free and what is its classification?
It is regulated under FDA 510(k) clearance K220653, granted as substantially equivalent on May 6, 2022, and is classified as a Class 2 device with product code NUC.
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 Glycerin & Paraben Free by BioFilm Inc. | FDA 510(k) Summary, K220653 - Astroglide Glycerin & Paraben Free - FDA 510 (k), GLYCERIN & PARABEN FREE ASTROGLIDE by BIOFILM, INC. | FDA 510 (k) Summary, Astroglide Glycerin & Paraben Free 510(k) K220653 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220653 | Class II | Active |
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Manufacturer
- Manufacturer
- Biofilm, Inc
- FDA Applicant
- Biofilm, Inc.
Sources (1)
- FDA 510(k) K220653 24 fields · synced Sep 24, 2026