CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawber…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201067 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)
The Cupid Brand Male Natural Rubber Latex Condoms are barrier contraceptives designed to prevent pregnancy and reduce the risk of sexually transmitted infections. These condoms provide a physical barrier between partners during sexual intercourse, ensuring protection through their latex material and snug fit options, including plain (banana and strawberry), dotted, and multi-textured variants.
These condoms are supplied as single-use, non-sterile devices intended for use in the setting of sexual health and contraception. They are classified as Class II medical devices under FDA regulations and comply with the Medical Device Directive (MDD) in the EU. Each variant is packaged individually for convenience, and no special storage conditions are required beyond protection from extreme temperatures or physical damage. Authorisations include FDA 510(k) clearance and MDD compliance.
Frequently asked questions
What are the different textures and styles available for the Cupid Brand Male Natural Rubber Latex Condoms, and how might they affect use?
The Cupid Brand Male Natural Rubber Latex Condoms come in four distinct styles: plain (banana and strawberry), dotted, and multi-textured (which combines dotted, contoured, and ribbed textures). These textures are designed to enhance sensory experience and fit, with the multi-textured variant offering varied tactile stimulation to potentially improve comfort and satisfaction during use.
Are these condoms intended for single-use only, and if so, why?
Yes, these condoms are explicitly designed for single-use only. The manufacturer emphasizes this to ensure hygiene and effectiveness, as reuse could compromise the integrity of the latex barrier, increasing the risk of failure in preventing pregnancy or sexually transmitted infections.
Do these condoms require any special storage conditions, and if not, what precautions should be taken?
No special storage conditions like refrigeration are required, but they should be kept protected from extreme temperatures (such as freezing or excessive heat) and physical damage. Storing them in a cool, dry place—like a drawer or bedside table—helps maintain their quality and integrity until use.
Are these condoms sterile, and if not, what does that mean for their use?
These condoms are not sterile, meaning they are not processed to eliminate all microorganisms. While they are intended for contraception and infection prevention, they are not intended for surgical or invasive medical procedures where sterility is required. The lack of sterility is explicitly stated in the product description, so users should rely on proper hygiene practices before and after use.
What regulatory pathways have these condoms followed, and how does that affect their availability?
The Cupid Brand Male Natural Rubber Latex Condoms have undergone FDA 510(k) clearance and comply with the EU’s Medical Device Directive (MDD). The FDA classification as a Class II device and the MDD compliance indicate they meet established safety and performance standards for barrier contraceptives. This regulatory route ensures their availability in markets adhering to these standards, including the U.S. and EU.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K201067 | Class II | Active |
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Manufacturer
- Manufacturer
- Cupid Limited
Sources (2)
- FDA 510(k) K201067 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026