Trojan Her Pleasure Warming Male Natural Rubber Latex Condom with Warming Lubricant
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221431 FDA 510(k)
- FDA Product Code
- HIS 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)
This device is a male condom (condom, male) designed for contraception and prophylactic use. It is constructed from natural rubber latex and incorporates a warming lubricant to enhance sensory experience during use. The product is intended to prevent sexually transmitted infections and unintended pregnancies while providing additional tactile stimulation.
The Trojan Her Pleasure Warming Male Natural Rubber Latex Condom with Warming Lubricant is supplied as a single-use, non-sterile device. It is classified as a Class II medical device under FDA regulation 884.5300 and received FDA 510(k) clearance (K221431) in 2022. The device is intended for use in obstetrics/gynecology settings and must be stored in a cool, dry place away from direct sunlight. No MRI safety information is provided.
Frequently asked questions
What is the Trojan Her Pleasure Warming condom designed for?
The Trojan Her Pleasure Warming condom is designed for contraception and prophylactic use, meaning it helps prevent unintended pregnancies and sexually transmitted infections (STIs). The warming lubricant incorporated into the natural rubber latex material also enhances tactile stimulation during use, improving sensory experience.
Is this condom sterile and intended for single-use?
No, this condom is supplied as a single-use, non-sterile device. It is intended for one-time use only and should not be reused, as reuse can compromise its effectiveness and increase the risk of breakage or infection.
How should I store the Trojan Her Pleasure Warming condom?
Store the condom in a cool, dry place away from direct sunlight. Avoid extreme temperatures or humidity, as these conditions can degrade the latex material and reduce its effectiveness or durability.
What regulatory classification does this condom hold?
This device is classified as a Class II medical device under FDA regulation 884.5300. It received FDA 510(k) clearance (K221431) in 2022, demonstrating it is substantially equivalent to a legally marketed predicate device.
Is this condom safe for use with MRI machines?
No MRI safety information is provided for this condom. If MRI use is required, consult the manufacturer or a healthcare provider to ensure compatibility and safety.
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: TROJAN (TM) Her Pleasure Warming male natural rubber latex condom with ..., TROJAN (TM) Her Pleasure Warming male natural rubber latex condom with ..., Her Pleasure™ Lubricated Condoms | Textured Condoms for Her - Trojan, Trojan (tm) Her Pleasure Warming Male Natural Rubber Latex Condom With ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221431 | Class II | Active |
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Manufacturer
- Manufacturer
- Church & Dwight Co., Inc.
Sources (1)
- FDA 510(k) K221431 24 fields · synced Oct 1, 2026