The SKORE Bulbous Dots & Ribs Natural is made of natural rubber latex.It is a bulbous teat ended, fully textured, transparent male condom. It meets the requirements as specified in ASTM D…
The SKORE Bulbous Dots & Ribs Natural is made of natural rubber latex.It is a bulbous teat ended, fully textured, transparent male condom. It meets the requirements as specified in ASTM D 3492 standard for rubber latex contraceptives (Male condoms). The Skore bulbous dots and ribs 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 Bulbous Dots AND Ribs | 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 | 2016-10-03 |
| Record revised | 2018-08-15 (version 4) |
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 | Pack of 2160, pack of 240 |
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.