Identifiers
- 510(k) Number
- K193448 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)
A personal lubricant intended for use in obstetrics and gynecology. It is a device classified as a lubricant, personal, under FDA regulation number 884.5300.
Supplied as a non-sterile, single-use product. It is authorized via FDA 510(k) clearance (K193448) and is substantially equivalent to a predicate device. No MRI safety, size, or storage specifications are provided in the data.
Frequently asked questions
What is BioNourish Lubricant intended for?
BioNourish Lubricant is intended for use as a personal lubricant in obstetrics and gynecology, as specified in its FDA classification under regulation number 884.5300 for lubricants, personal.
Is BioNourish Lubricant sterile or non-sterile, and is it single-use or reusable?
BioNourish Lubricant is supplied as a non-sterile, single-use product, meaning it is not sterilized and is designed for one-time use only to reduce cross-contamination risk in clinical settings.
How is BioNourish Lubricant supplied and what are its packaging details?
The device is supplied as a non-sterile, single-use personal lubricant; however, specific package sizes, volumes, or container types are not detailed in the provided device data.
What regulatory pathway was used for BioNourish Lubricant's market authorization?
BioNourish Lubricant received market authorization through the FDA 510(k) pathway, with clearance number K193448, demonstrating substantial equivalence to a predicate device.
Are there any special storage, handling, or MRI safety considerations for BioNourish Lubricant?
No MRI safety, size, or storage specifications are provided in the device data, so no specific storage conditions, handling precautions, or MRI compatibility claims can be inferred from the available information.
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: Feminine Hygiene & Organic Personal Lubricants | Good Clean Love, Vaginal Care Products - Good Clean Love, Good Clean Love: BioNourish® Vaginal Gel with Hyaluronic Acid, 2 oz ..., Good Clean Love - store.mayoclinic.com, Good Clean Love BioNude Ultra Sensitive Personal Lubricant 3 fl. oz ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193448 | Class II | Active |
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Manufacturer
- Manufacturer
- Good Clean Love, Inc.
Sources (1)
- FDA 510(k) K193448 24 fields · synced Sep 21, 2026