Suzhou Colour-Way New Material Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 5 device types, 3 clearances.
Suzhou Colour-way New Material Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Condom, Surgeon’S Gloves and 3 other device types. Its earliest product listing with the FDA dates from 2009.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3008062466 |
| FEI number | 3008062466 |
| Establishment type | Manufacturer |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | No. 20, Anmin Road, Huangdai Town, Xiangcheng District |
| Postal code | 215152 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Apron, Protective | Class 1 | Radiation protection cap, Thyroid collar | 2023 | 46 |
| Condom | Class 2 | Jass Duro, Male Latex Condoms, Jass Duro, m. Dior, S Shock Shark Condoms | 2009 | 9 |
| Radiographic Protective Glove | Class 1 | Radiation Protection Gloves | 2018 | 30 |
| Shield, Protective, Personnel | Class 1 | Radiation protection sleeve | 2023 | 78 |
| Surgeon’S Gloves | Class 1 | Sterilized Latex Surgical Gloves, Polyisoprene Surgical gloves, Powdered Latex Surgeon’s Glove | 2013 | 10 |
Clearances
3 clearances name Suzhou Colour-way New Material Co., Ltd. as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K240790 | 2024-08-23 | KGO | Traditional | This company |
| K222620 | 2023-03-23 | KGO | Traditional | This company |
| K222611 | 2022-11-28 | HIS | Traditional | This company |
| K121925 | 2013-08-28 | KGO | Abbreviated | Suzhou Colour-Way Enterprise Development Co., Ltd. |
| K083817 | 2009-09-16 | HIS | Abbreviated | Suzhou Colour-Way Enterprise Development Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1958 |
|---|---|
| Main products | Latex surgical gloves, Examination gloves, Male latex condoms, Polyurethane condoms |
| Certifications | CE, FDA, ISO 9001, ISO 14001, WHO/UNFPA prequalified |
| Export markets | Asia, Africa, Europe, America |
| OEM and ODM | Offered |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.