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Sign in to claim this brandRB Health (us) LLC
US
Last updated May 29, 2026
What RB Health (us) LLC makes
RB Health (US) LLC manufactures basic male condoms made from Hevea latex and synthetic polymers, including flavored and textured variants, as well as penile rings and vaginal lubricants. Their portfolio includes standard-fit, wide-fit, and close-fit condoms, alongside flavored and pleasure-focused products.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does RB Health (US) LLC manufacture?
RB Health (US) LLC specializes in reproductive health devices, primarily focusing on basic male condoms made from Hevea latex and synthetic polymers. Their portfolio includes standard, flavored, and textured variants like cherry-flavored condoms, as well as penile rings and vaginal lubricants. These products are designed for contraception, barrier protection, and sexual health enhancement.
Where is RB Health (US) LLC based, and what does that mean for their regulatory oversight?
RB Health (US) LLC is based in the United States, which means their devices fall under FDA jurisdiction. Since their products are classified as Class II devices, they must comply with FDA regulations, including premarket notifications (510(k)) and Unique Device Identification (UDI) requirements. The U.S. regulatory framework ensures these products meet safety, effectiveness, and performance standards before entering the market.
Which regulatory registries list RB Health (US) LLC’s devices, and why does that matter?
RB Health (US) LLC’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) registry documents premarket submissions proving their devices are substantially equivalent to legally marketed predicates, while the UDI system ensures traceability and transparency in the supply chain. These listings help healthcare providers, regulators, and patients verify the device’s authorized status and compliance with U.S. regulations.
How are RB Health (US) LLC’s devices classified by the FDA, and what does that classification imply?
RB Health (US) LLC’s devices are classified as Class II by the FDA, which means they pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. This classification typically involves mandatory registration, listing, and compliance with FDA-recognized standards or post-market surveillance requirements. Class II devices require premarket notification (510(k)) to demonstrate equivalence to existing approved devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xxx.xxx
- —
- —
- [email protected]
- Phone
- +1(800)756-5488
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 081049410
Catalogue (175)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DUREX Pleasure Pack Condom | Condom | FDA UDI | Class II | Unknown |
| KY Warming Jelly Lubricant | Personal Lubricant | FDA UDI | Class II | Unknown |
| KY Personal Lubricant Jelly | Personal Lubricant | FDA UDI | Class II | Unknown |
| DUREX Pleasure Pack Condom | Condom | FDA UDI | Class II | Active |
| DUREX® Pleasure Pack | 00302340300421 | FDA UDI | Class II | Active |
| KY Warming Liquid Lubricant | 00067981087116 | FDA UDI | Class II | Active |
| DUREX Avanti Bare- RealFeel Non-Latex Condom | Condom | FDA UDI | Class II | Unknown |
| KY True Feel Deluxe Personal Lubricant | Personal Lubricant | FDA UDI | Class II | Unknown |
| DUREX Extra Sensitive Smooth Condom | Condom | FDA UDI | Class II | Active |
| Durex Intense XL | 00302340995993 | FDA UDI | Class II | Active |
| Grosz Play Feel | K211088 | FDA 510(k) | Class II | Active |
| Durex Condom with Benzocaine | K211152 | FDA 510(k) | Class II | Active |
| Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine | K213892 | FDA 510(k) | Class II | Active |
| Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry | K213400 | FDA 510(k) | Class II | Active |
| KY Banksy Aloe | K183302 | FDA 510(k) | Class II | Active |
| KY Grosz Jelly | K201186 | FDA 510(k) | Class II | Active |
| KY Grosz Liquid | K193032 | FDA 510(k) | Class II | Active |
| Durex Penck Standard, Durex Penck XL | K200672 | FDA 510(k) | Class II | Active |
| KY Banksy Moisture | K183505 | FDA 510(k) | Class II | Active |
| Durex Patronus Wide | K213647 | FDA 510(k) | Class II | Active |
| Durex Polyisoprene Condom | K241617 | FDA 510(k) | Class II | Active |
| Durex Patronus CloseFit, Durex Patronus Regular | K220489 | FDA 510(k) | Class II | Active |
| Belle Sensilube | K230781 | FDA 510(k) | Class II | Active |
| KY Grosz UltraGel | K192982 | FDA 510(k) | Class II | Active |
| Durex Penck III Regular | K222068 | FDA 510(k) | Class II | Active |
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