Hubei Kangning Protective Products Co., Ltd.
Registered establishment in Xiantao, Hubei, China. 6 device types, 1 clearance.
Hubei Kangning Protective Products Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Cap, Surgical, Mask, Surgical and 4 other device types. Its earliest product listing with the FDA dates from 2017.
6device types registered with the FDA
1510(k) clearance
Registration
| Registered name | HUBEI KANGNING PROTECTIVE PRODUCTS CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006799943 |
| FEI number | 3006799943 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 湖北康宁防护用品有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Xiantao |
|---|---|
| Province | Hubei |
| Address | SPECIAL NO.1, XUEFU ROAD, XIANTAO CITY, |
| Postal code | 433000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Sleeve covers, Face mask, Mob cap, Bed covers, Pillow case | 2017 | 439 |
| Bedding, Disposable, Medical | Class 1 | Medical sheet | 2017 | 308 |
| Cap, Surgical | Class 1 | bouffant cap; surgical cap | 2017 | 178 |
| Cover, Shoe, Operating-Room | Class 1 | Shoe Cover | 2017 | 176 |
| Mask, Surgical | Class 2 | Surgical Face Mask | 2021 | 125 |
| Non-Surgical Gown | Class 1 | Isolation gown, lab coat, coverall, PE coat gown | 2017 | 318 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K211363 | 2021-07-24 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1998 |
|---|---|
| Employees | 300 |
| Factory area | 30000 |
| Main products | Disposable protective suits, Surgical gowns, Face masks, Caps, Shoe covers |
| Certifications | CE, ISO13485, ISO9001, BSCI, EN14683, EN13795, ASTM Level 2, UKCA, FDA 510K |
| Export markets | 40 countries |
| 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.
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