Data / Medical devices / China / Suzhou Colour-way New Material Co., Ltd.
Suzhou Colour-way New Material Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 5 510(k) clearances
Suzhou Colour-way New Material Co., Ltd. is registered with the FDA (registration 3008062466) in Suzhou Jiangsu, China. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008062466
- Address
- No. 20, Anmin Road, Huangdai Town, Xiangcheng District, Suzhou Jiangsu, China, 215152
- Owner or operator
- Suzhou Colour-way New Material Co., Ltd. (10030755)
- Roles
- Manufacturer
- First device listed
- November 8, 2009
- Registered through
- 2026
- Brand names listed
- Jass Duro, Male Latex Condoms, Jass Duro, m. Dior, S Shock Shark Condoms, Polyisoprene Surgical gloves, Powdered Latex Surgeon's Glove, Radiation Protection Gloves, Radiation protection cap, Thyroid collar, Radiation protection sleeve, Sterilized Latex Surgical Gloves
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apron, Protective | IWO | 1 | Manufacturer | accessdata.fda.gov |
| Condom | HIS | 2 | Manufacturer | accessdata.fda.gov |
| Radiographic Protective Glove | IWP | 1 | Manufacturer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 23, 2024 | K240790 | Polyisoprene Surgical gloves | KGO | Substantially Equivalent | Suzhou Colour-Way New Material Co., Ltd. | accessdata.fda.gov |
| March 23, 2023 | K222620 | Sterilized Latex Surgical Gloves | KGO | Substantially Equivalent | Suzhou Colour-Way New Material Co., Ltd. | accessdata.fda.gov |
| November 28, 2022 | K222611 | Male Latex Condoms | HIS | Substantially Equivalent | Suzhou Colour-Way New Material Co., Ltd. | accessdata.fda.gov |
| August 28, 2013 | K121925 | POWDERED LATEX SURGEON'S GLOVE | KGO | Substantially Equivalent | Suzhou Colour-Way Enterprise Development Co., Ltd. | accessdata.fda.gov |
| September 16, 2009 | K083817 | M. DIOR BRAND | HIS | Substantially Equivalent | Suzhou Colour-Way Enterprise Development Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Condom
- All makers of Radiographic Protective Glove
- All makers of Surgeon'S Gloves
- All makers of Shield, Protective, Personnel
- All makers of Apron, Protective
Updated August 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.