Royal
26 catalogue numbers from Royal Strawberry Condoms Box of 10, listed by M3 Global Enterprises, LLC, United States, under Condom. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
26catalogue numbers in this listing
1510(k) clearance
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 | M3 Global Enterprises, LLC, United States |
|---|---|
| FDA product code | HIS |
| Device type | Condom |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5300 |
| 510(k) | K161195 |
| Record published | 2016-10-12 |
| Record revised | 2024-04-22 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2024-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Royal Strawberry Condoms Box of 10 | In distribution | |
| Royal Natural Condoms Box of 10 | In distribution | |
| Royal Chocolate Condoms Box of 3 | In distribution | |
| Royal Ultra Thin Natural Condoms Box of 20 | In distribution | |
| Royal Ultra Thin Natural Condoms Box of 10 | In distribution | |
| Royal Ultra Thin Natural XL Condoms Box of 10 | In distribution | |
| Royal Strawberry Condoms Box of 3 | In distribution | |
| Royal Chocolate Condoms Box of 20 | In distribution | |
| Royal Ultra Thin Natural XL Condoms Box of 20 | In distribution | |
| Royal Chocolate Condoms Box of 10 | In distribution | |
| Royal Strawberry Condoms Box of 20 | In distribution | |
| Royal Natural Condoms Box of 3 | In distribution | |
| Royal Natural Condoms Box of 10 | Withdrawn | |
| Royal Natural Condoms Box of 3 | Withdrawn | |
| Royal Strawberry Condoms Box of 20 | Withdrawn | |
| Royal Black Grape Condoms Box of 10 | Withdrawn | |
| Royal Strawberry Condoms Box of 3 | Withdrawn | |
| Royal Chocolate Condoms Box of 20 | Withdrawn | |
| Royal Coffee Condoms Box of 3 | Withdrawn | |
| Royal Strawberry Condoms Box of 10 | Withdrawn | |
| Royal Chocolate Condoms Box of 10 | Withdrawn | |
| Royal Chocolate Condoms Box of 3 | Withdrawn | |
| Royal Natural Condoms Box of 20 | Withdrawn | |
| Royal Strawberry Condoms Box of 12 | Withdrawn | |
| Royal Black Grape Condoms Box of 3 | Withdrawn | |
| Royal Coffee Condoms Box of 20 | 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 |
| Handy Solutions | Navajo Manufacturing Company | 35 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161195 | 2016-08-25 |
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.