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Grosz Play Feel

FDA 510(k)

Class II (US FDA 510(k))

510(k) K211088

by RB Health (us) LLC

Identifiers

510(k) Number
K211088 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 Grosz Play Feel is a Personal Lubricant designed to enhance comfort and reduce friction during intimate activities. It is classified under the FDA product code NUC (Non-Urethral Condom) and falls under the regulatory category for obstetrics and gynecology devices. This lubricant is intended for use as a personal hygiene and comfort aid, ensuring smooth application and sensory experience.

Supplied as a single-use product, the Grosz Play Feel is intended for non-medical, personal use in intimate settings. It is regulated under 21 CFR § 884.5300 and has received FDA 510(k) clearance through the Traditional pathway, with a clearance decision dated July 9, 2021. The device is not sterile and is not intended for medical or clinical procedures. It is supplied in various sizes and formulations, as indicated by the listed registration numbers, and is manufactured by RB Health (US) LLC.

Frequently asked questions

What is the Grosz Play Feel Personal Lubricant intended for?

The Grosz Play Feel is a personal lubricant designed to enhance comfort and reduce friction during intimate activities. It is classified under FDA product code NUC (Non-Urethral Condom) and is intended for non-medical, personal use as a hygiene and comfort aid. It is not intended for medical or clinical procedures.

How is the Grosz Play Feel supplied, and is it sterile?

The Grosz Play Feel is supplied as a single-use product in various sizes and formulations, as indicated by the registration numbers. It is not sterile, which is explicitly stated in the product description. Non-sterility is typical for personal lubricants intended for non-medical use.

Is the Grosz Play Feel reusable, or is it meant for one-time use?

The Grosz Play Feel is explicitly labeled as a single-use product. This designation ensures hygiene and safety for personal use, as reusing personal lubricants could introduce contamination or reduce effectiveness.

What regulatory pathway was followed for FDA clearance, and what does that mean?

The Grosz Play Feel received FDA 510(k) clearance through the Traditional pathway, with a decision dated July 9, 2021. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, meaning it meets the same performance standards and safety requirements as an existing, approved product.

How do I identify the correct size or formulation for my needs?

The Grosz Play Feel comes in multiple sizes and formulations, each identified by unique registration numbers (e.g., 3010409218, 3013414814). These variations allow users to select the texture or viscosity best suited for their comfort and preferences. Check the packaging or consult the manufacturer for guidance on choosing the right variant.

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: K211088 - Grosz Play Feel | FDA 510 (k) | Rb Health (Us), LLC, Grosz Play Feel (K211088) — FDA 510 (k) | Innolitics, Grosz Play Feel 510 (k) FDA Premarket Notification K211088 RB Health ..., 510(k) Premarket Notification - accessdata.fda.gov

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
RB Health (us) LLC
FDA Applicant
Rb Health (Us), LLC

Sources (1)

  • FDA 510(k) K211088 24 fields · synced Oct 5, 2026