Handy Solutions
Trojan Magnum Condoms
9manufacturers in China registered for this device type
35catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Armocon Technology Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 5 |
| Dalian Latex Co Ltd | Dalian | Liaoning | Contract manufacturer | 1 |
| Rfx+care Manufacturing Co., Ltd. | Shaoxing | Zhejiang | Repacker / relabeller | 21 |
| Suzhou Colour-way New Material Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
| Shanghai Jinxiang Latex Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 3 |
| Shanghai Personage Hygiene Products Co., Ltd. | Shanghai | Shanghai | Manufacturer | 1 |
| Guangzhou Double One Latex Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 1 |
| Qingdao London Durex Co., Ltd. | Qingdao | Shandong | Manufacturer | 1 |
| Shaoguan Regenex Pharmaceutical Co., Ltd. | Shaoguan | Guangdong | Manufacturer | 1 |
Record
| Listed by | Navajo Manufacturing Company, United States |
|---|---|
| FDA product code | HIS |
| Device type | Condom |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5300 |
| Establishment | Repacker / relabeller, Complaint-file establishment |
| 510(k) | K033076 |
| Record published | 2016-08-31 |
| Record revised | 2025-03-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2023-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 31232 | In distribution | |
| 28138 | Withdrawn | |
| 26102 | Withdrawn | |
| 26103 | Withdrawn | |
| 26101 | Withdrawn | |
| 28141 | Withdrawn | |
| 26104 | Withdrawn | |
| 26103 | Withdrawn | |
| 26104 | Withdrawn | |
| 28138 | Withdrawn | |
| 26103 | Withdrawn | |
| 28141 | Withdrawn | |
| 29048 | Withdrawn | |
| 26101 | Withdrawn | |
| 26101 | Withdrawn | |
| 26119 | Withdrawn | |
| 26103 | Withdrawn | |
| 26119 | Withdrawn | |
| 29048 | Withdrawn | |
| 26119 | Withdrawn | |
| 26101 | Withdrawn | |
| 28141 | Withdrawn | |
| 26102 | Withdrawn | |
| 26104 | Withdrawn | |
| 28141 | Withdrawn | |
| 28138 | Withdrawn | |
| 26101 | Withdrawn | |
| 29048 | Withdrawn | |
| 26104 | Withdrawn | |
| 26119 | Withdrawn | |
| 28141 | Withdrawn | |
| 26103 | Withdrawn | |
| 26104 | Withdrawn | |
| 26102 | Withdrawn | |
| 26119 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lifestyles | Suretex Limited – Branch | 158 |
| Custom Condoms | Global Protection Corp. | 94 |
| My One | Global Protection Corp. | 51 |
| ONE | Global Protection Corp. | 45 |
| Keypers | Global Protection Corp. | 38 |
| Royal | M3 Global Enterprises, LLC | 26 |
| b condoms | B Holding Group LLC | 22 |
| ONE | Lunamax LLC | 20 |
| Kimono | Mayer Laboratories | 20 |
| Trustex lubricated Condoms | Global Protection Corp. | 18 |
| Primeros | Richter Rubber Technology SDN. BHD. | 18 |
| ID Condoms | Westridge Laboratories, Inc | 17 |
Showing 12 of 688. All products under Condom
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Gold Star Distribution Inc | 510(k) number | 2025-12-26 | Class II | Storage | Potential exposure of rodents and rodent activity in the distribution center. | unknown |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.