Prudence Sensitive
3 catalogue numbers from Condom, listed by DKT de México, S.A. de C.V., under Condom. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
3catalogue 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 | DKT de México, S.A. de C.V. |
|---|---|
| FDA product code | HIS |
| Device type | Condom |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5300 |
| 510(k) | K012665 |
| Record published | 2018-06-20 |
| Record revised | 2019-11-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Condom | 3 | In distribution | |
| Condom | 12 | In distribution | |
| Condom | 48 | In distribution |
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 |
| Handy Solutions | Navajo Manufacturing Company | 35 |
| 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 |
Showing 12 of 688. All products under Condom
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.