JO H2O Jelly Original Personal Lubricant

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K183584 ↗

FDA Product Code

NUC

Device Class

Class II

Regulation

21 CFR Part 884.5300

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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See all devices from United Consortium →

• What is the primary purpose of the JO H2O Jelly Original Personal Lubricant, and where is it intended to be applied?

  The JO H2O Jelly Original Personal Lubricant is designed to supplement natural lubrication during sexual activity. It is intended for topical application on penile, anal, or vaginal areas to enhance comfort.

• How is the JO H2O Jelly Original Personal Lubricant packaged and supplied for consumer use?

  The lubricant is supplied in 4-ounce polyethylene tubes with a polypropylene flip-top cap, making it convenient for over-the-counter consumer use. Each tube is intended for multiple applications.

• Is the JO H2O Jelly Original Personal Lubricant sterile, and can it be reused?

  No, the JO H2O Jelly Original Personal Lubricant is explicitly labeled as non-sterile. However, it is designed for multiple applications per tube, meaning it can be reused for several uses before the contents are depleted.

• What regulatory pathway was followed for FDA clearance of this lubricant, and which advisory committee was involved?

  The JO H2O Jelly Original Personal Lubricant received 510(k) clearance (K183584) through the traditional review pathway, classified as substantially equivalent to a predicate device. The Obstetrics/Gynecology (OB) Advisory Committee was involved in the review process.

• What type of device classification does the JO H2O Jelly Original Personal Lubricant fall under, and what is its intended use category?

  The JO H2O Jelly Original Personal Lubricant is classified as a Class II medical device under FDA regulation 884.5300, specifically categorized as a personal lubricant. Its intended use category is reflected in the product code NUC and aligns with the Obstetrics/Gynecology specialty.