The Sustain Natural Extra large Ribs and Dots is made of natural rubber latex. It is a bulbous teat ended, fully textured, transparent male condom. it meets the requirements as specified in…
The Sustain Natural Extra large Ribs and Dots 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 D3492 standard for rubber latex contraceptives (Male Condoms). The Sustain Natural Extra large Ribs and Dots 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 Sustain Natural Extra Large Ribs and Dots. | 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 | 2018-05-10 |
| Record revised | 2018-08-15 (version 3) |
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 |
| Storage | Special storage condition: Store condoms in a cool, dry place ( below 100deg.F). Avoid exposure to direct sunlight. |
| Packaging | Box of 144, box of 10, box of 3, case of 18, carton of 1152, case of 60 |
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.