Data / Medical devices / China / Hubei Kimsoul Industrial Co.,ltd
Hubei Kimsoul Industrial Co.,ltd: FDA-registered device maker in Xiantao Hubei, China, 1 510(k) clearance
Hubei Kimsoul Industrial Co.,ltd is registered with the FDA (registration 3014198412) in Xiantao Hubei, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 15, 2021. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3014198412
- Address
- NO.1 Guohezhen industrial zone, Xiantao Hubei, China, 433000
- Owner or operator
- HUBEI KIMSOUL INDUSTRIAL CO.,LTD (10066643)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer
- First device listed
- April 2, 2020
- Registered through
- 2026
- Brand names listed
- 3D face mask, Coverall, Disposable face mask, Surgical Face Mask (Non-sterile);Model:2020,2030, isolation gown
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor | 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 |
|---|---|---|---|---|---|---|
| December 15, 2021 | K212398 | Surgical Face Mask (Non-sterile) | FXX | Substantially Equivalent | Hubei Kimsoul Industrial Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Mask, Surgical
- All makers of Accessory, Surgical Apparel
- All makers of Non-Surgical Gown
Updated December 15, 2021. 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.