The SKORE Dots Natural condom is made of natural rubber latex. It is straight walled, dotted, teat ended, transparent male condoms. It meets the requirements as specified in ISO 4074:2015 –…
The SKORE Dots Natural condom is made of natural rubber latex. It is straight walled, dotted, teat ended, transparent 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 Dots Natural, natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
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.
Record
Regulatory record for Skore Dots Natural | 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) | K132490 |
| Record published | 2023-07-03 |
Specifications
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 |
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.