Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted Colors
by Suretex Prophylactics (India), Ltd.
510(k) K983320
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK983320 | Date11 Dec 1998 | StatusActive |
Recalls
-
- Terminated Z-0717-2013
One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HIS
- FDA applicant
- Suretex Prophylactics (India) , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5300
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Royale Brand Latex Condoms with Silicone Lubricant are a mechanical barrier contraceptive device designed to prevent pregnancy and sexually transmitted infections. Manufactured from latex, these condoms feature silicone-based lubrication for enhanced comfort and performance. They are available in colored or assorted color variants, providing additional user preference options while maintaining their primary function as a protective barrier during sexual intercourse.
These condoms are single-use items intended for one-time use per application. They are classified as Class II devices under FDA regulations and have received a 510(k) clearance (K983320). Supplied in sterile packaging, they must be stored in a cool, dry place away from direct sunlight to maintain integrity. No MRI safety considerations apply, as latex and silicone materials are non-magnetic. The product complies with FDA regulatory standards under 884.5300.
Royale Brand Latex Condoms with Silicone Lubricant (Colored or Assorted Colors)
Other devices from Suretex Prophylactics, Ltd.
Questions
AI-generated answers, 20 Sep 2026
Are these condoms reusable or intended for single-use only?
These Royale Brand Latex Condoms with Silicone Lubricant are explicitly designed for single-use only. The manufacturer’s description and classification as a Class II device confirm they are meant to be used once per application to ensure effectiveness in preventing pregnancy and sexually transmitted infections.
How should I store these condoms to maintain their integrity?
The packaging states these condoms must be stored in a cool, dry place away from direct sunlight. Proper storage ensures the latex material remains intact and the silicone lubricant retains its properties, preserving both sterility and functionality.
Are these condoms available in multiple sizes, and if so, how do I identify them?
While the provided data does not list specific size measurements, the product is categorized under OpenFDA’s product codes for condoms (HIS classification) and includes multiple FEI numbers, suggesting variations in packaging or branding (e.g., assorted colors). Sizes are typically standardized for latex condoms, but users should refer to the packaging or manufacturer’s sizing guide for exact fit recommendations.
Do these condoms require any special handling or disposal after use?
As single-use items, these condoms should be discarded immediately after use in a sealed waste container. The latex material is non-biodegradable, so proper disposal in regular household trash is recommended. No special handling (e.g., sterilization or reprocessing) is required or intended.
Are there any safety concerns with these condoms, such as MRI compatibility or material allergies?
The condoms are made from latex and silicone, both of which are non-magnetic and do not pose MRI safety risks. However, users with latex allergies should avoid these condoms, as latex is the primary material. The silicone lubricant is designed for comfort but does not alter the core safety profile beyond standard latex condom precautions.