Skore Dotted Condoms
Skore Dotted Condoms are natural rubber latex male condoms intended to help prevent pregnancy and transmission of sexually transmitted infections. A close-fitting latex sheath covers the…
Skore Dotted Condoms are natural rubber latex male condoms intended to help prevent pregnancy and transmission of sexually transmitted infections. A close-fitting latex sheath covers the penis during use.
The Belgian chocolate and vanilla versions have straight walls, raised dots and a teat end. The dotted range is described with brown coloring and chocolate or vanilla formulations.
Listed Item
The SKORE Dotted Condoms – SKORE Belgian chocolate condom is made of natural rubber latex. It is straight walled, dotted, teat ended, brown colored, Belgian chocolate flavored male condoms. It meets the requirements as specified in ISO 4074:2015 → Natural rubber latex male condoms → Requirements and test methods and ASTM D3492:2016 → Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Dotted Condoms – SKORE Belgian chocolate natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
Dimensions
The specified length is 190 ± 10 mm and width is 53 ± 2 mm. Thickness for the dotted versions is 0.060 to 0.080 mm, distinguishing these variants from the separately described smooth and thin products.
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 | TTK Healthcare Limited, India |
|---|---|
| FDA product code | HIS |
| Device type | Condom |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5300 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K230049 |
| Record published | 2025-01-31 |
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 |
| Packaging | Wallet of 3, carton of 240, case of 2160 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SKORE Dots – Vanilla | In distribution | |
| SKORE Belgian Chocolate | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230049 | 2023-09-07 |
| K213547 | 2021-12-23 |
| K202403 | 2021-04-15 |
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.