Data / Medical devices / China / Hubei Kangning Protective Products Co., Ltd
Hubei Kangning Protective Products Co., Ltd: FDA-registered device maker in XIanTao Hubei, China, 1 510(k) clearance
Hubei Kangning Protective Products Co., Ltd is registered with the FDA (registration 3006799943) in XIanTao Hubei, China. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 24, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006799943
- Address
- Special No.1, Xuefu Road, Xiantao City, XIanTao Hubei, China, 433000
- Owner or operator
- HUBEI KANGNING PROTECTIVE PRODUCTS CO., LTD (10054730)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 20, 2017
- Registered through
- 2026
- Brand names listed
- Bed covers, Face mask, Isolation gown, Medical sheet, Mob cap, PE coat gown, Pillow case, Shoe Cover and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| July 24, 2021 | K211363 | Medical Face Mask | FXX | Substantially Equivalent | Hubei Kangning Protective Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Surgical
- All makers of Accessory, Surgical Apparel
- All makers of Non-Surgical Gown
- All makers of Bedding, Disposable, Medical
- All makers of Cap, Surgical
- All makers of Cover, Shoe, Operating-Room
Updated July 24, 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.