Ah!Yes Ob Coco Personal Lubricant
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191411 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)
The Ah!Yes Ob Coco Personal Lubricant is a plant-oil-based personal lubricant designed for intimate use. It is classified as a lubricant, personal, and consists primarily of sunflower oil and fractionated coconut oil, intended to supplement natural lubrication during sexual activity.
This non-sterile product is supplied in a single-use polyethylene applicator and is intended for vaginal or penile application. It is classified under FDA regulation number 884.5300, with a clearance type of Traditional 510K (K191411), and is intended for use in obstetrics/gynecology settings. The device is not sterile and is not reusable.
Frequently asked questions
What types of intimate applications is the Ah!Yes Ob Coco Personal Lubricant intended for, and how is it different from natural lubrication?
The Ah!Yes Ob Coco Personal Lubricant is designed to supplement natural lubrication during sexual activity and is specifically intended for vaginal or penile application. It is formulated with plant-based oils—sunflower oil and fractionated coconut oil—to provide additional moisture and reduce friction, which can enhance comfort and ease of movement during intimate activities.
Is the Ah!Yes Ob Coco Personal Lubricant sterile, and how should it be stored to maintain its integrity?
The Ah!Yes Ob Coco Personal Lubricant is not sterile, so it should not be used in sterile medical procedures. It is supplied in a single-use polyethylene applicator, which means each unit is intended for one-time use only. To maintain its integrity, store the product in a cool, dry place away from direct sunlight, as exposure to heat or moisture could degrade its formulation.
What sizes or models of the Ah!Yes Ob Coco Personal Lubricant are available, and how is it packaged?
The Ah!Yes Ob Coco Personal Lubricant is supplied in a single-use polyethylene applicator, but the exact volume or specific model variations are not detailed in the provided data. The packaging is designed for one-time use, ensuring hygiene and convenience for intimate applications. If multiple sizes are available, they would likely be differentiated by applicator capacity or packaging design.
How was the regulatory approval for this product determined, and what does the classification under FDA regulation 884.5300 mean?
The Ah!Yes Ob Coco Personal Lubricant received FDA clearance through a Traditional 510(k) pathway (K191411), meaning it was determined to be substantially equivalent to a legally marketed predicate device. The classification under FDA regulation 884.5300 categorizes it as a personal lubricant, specifically for obstetrics/gynecology use, though this does not imply clinical indications beyond supplementing natural lubrication during sexual activity.
Can the Ah!Yes Ob Coco Personal Lubricant be reused, or is it designed for single-use only?
The Ah!Yes Ob Coco Personal Lubricant is explicitly designed for single-use only and is not intended for reuse. Each unit is packaged in a polyethylene applicator, which aligns with hygiene standards for intimate applications. Reusing the product could compromise sterility and increase the risk of contamination or irritation.
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: Ah!Yes Ob Coco Personal Lubricant (K191411) - Innolitics, PDF February 6, 2020 Bio-Tech Lubricants Ltd UNITED KINGDOM, AH! YES | Certified Organic Intimate Wellness
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191411 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio-Tech Lubricants, Ltd.
Sources (1)
- FDA 510(k) K191411 24 fields · synced Oct 6, 2026