Hubei Kimsoul Industrial Co., Ltd.
Registered establishment in Xiantao, Hubei, China. 4 device types, 1 clearance.
Hubei Kimsoul Industrial Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Surgical, Non-Surgical Gown and 2 other device types. Its earliest product listing with the FDA dates from 2020.
4device types registered with the FDA
1510(k) clearance
Registration
| Registered name | HUBEI KIMSOUL INDUSTRIAL CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014198412 |
| FEI number | 3014198412 |
| Establishment type | Contract manufacturer, Remanufacturer, Reprocessor, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
Location
| City | Xiantao |
|---|---|
| Province | Hubei |
| Address | NO.1 Guohezhen industrial zone |
| Postal code | 433000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | 3D face mask | 2022 | 439 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Disposable face mask | 2020 | 182 |
| Mask, Surgical | Class 2 | Surgical Face Mask (Non-sterile);Model:2020,2030 | 2021 | 125 |
| Non-Surgical Gown | Class 1 | Coverall, isolation gown | 2020 | 318 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K212398 | 2021-12-15 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1999 |
|---|---|
| Employees | 200 |
| Main products | Non-woven bags, Face masks, Surgical gowns, Polyester bags, Disposable products |
| Certifications | CE, FDA, ISO 9001, ISO 13485 |
| Export markets | Europe, North America, South America, Australia, Asia |
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.