Data / Medical devices / China / Xiantao Sanda Industrial Co., Ltd
Xiantao Sanda Industrial Co., Ltd: FDA-registered device maker in Xiantao Hubei, China, 1 510(k) clearance
Xiantao Sanda Industrial Co., Ltd is registered with the FDA (registration 3008048818) in Xiantao Hubei, China. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 13, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008048818
- Address
- No.46, East Of Huangjin Avenue,Xiantao, Xiantao Hubei, China, 433000
- Owner or operator
- XianTao Sanda Industrial Co., Ltd (10030643)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- October 27, 2009
- Registered through
- 2026
- Brand names listed
- BOUFFANT CAP, COVERALLS, Face mask, Fluid Impervious Gowns, Isolation gown, KNIFE SLEEVE, MEDICAL NURSING PAD, MEDICOM SHOE COVERS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | NTX | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| December 13, 2022 | K222651 | Surgical Face Mask | FXX | Substantially Equivalent | Xiantao Sanda Industrial Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Bedding, Disposable, Medical
- All makers of Handle, Scalpel
- All makers of Mask, Gas, Anesthetic
- All makers of Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
- All makers of Cover, Shoe, Operating-Room
- All makers of Non-Surgical Gown
Updated December 13, 2022. 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.