Mano and Mano Personal Lubricant
by Mano and Mano Proprietary Limited
510(k) K161585
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK161585 | Date6 Sep 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NUC
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5300
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Mano and Mano Personal Lubricant is a water-based personal lubricant designed to supplement natural lubrication. Classified as a personal lubricant (product code NUC), it is intended for over-the-counter use to enhance comfort during intimate sexual activity. The device is a clear, colorless gel formulated for topical application in sensitive areas.
This lubricant is supplied as a single-use, non-sterile product and is intended for use in non-invasive, non-surgical settings. It is regulated under FDA 510(k) clearance (K161585) with a decision of Substantially Equivalent (SESE) under regulation 884.5300. The device is classified as Class II under special controls and is intended for obstetrics/gynecology applications. Storage conditions are not specified in the regulatory data.
Questions
AI-generated answers, 1 Oct 2026
What is the Mano and Mano Personal Lubricant used for?
The Mano and Mano Personal Lubricant is a water-based gel intended to supplement natural lubrication during intimate sexual activity. It is designed to improve comfort and reduce friction in sensitive areas, making it suitable for over-the-counter use in non-invasive, non-surgical settings. Its formulation is specifically tailored for topical application in obstetrics/gynecology contexts.
Is the Mano and Mano Personal Lubricant sterile?
No, the Mano and Mano Personal Lubricant is classified as a non-sterile product. This is explicitly stated in the regulatory documentation, meaning it is not intended for use in sterile procedures or invasive medical settings. It is intended for non-invasive, over-the-counter use only.
How is the Mano and Mano Personal Lubricant supplied?
The Mano and Mano Personal Lubricant is supplied as a single-use product. This means each application requires a new unit, ensuring hygiene and reducing the risk of contamination. The packaging is designed for one-time use, aligning with its non-sterile classification and over-the-counter application.
What are the storage requirements for the Mano and Mano Personal Lubricant?
The regulatory data for the Mano and Mano Personal Lubricant does not specify any particular storage conditions. As a non-sterile, single-use product, it should be stored in a cool, dry place away from direct sunlight and out of reach of children. Always follow the instructions on the packaging if additional guidance is provided.
What regulatory approval does the Mano and Mano Personal Lubricant hold?
The Mano and Mano Personal Lubricant holds FDA 510(k) clearance under the classification of Substantially Equivalent (SESE) with the decision code K161585. It is categorized under product code NUC (personal lubricant) and falls under Class II with special controls, regulated under FDA regulation 884.5300. This clearance confirms its compliance for over-the-counter use in obstetrics/gynecology applications.