Xiantao Sanda Industrial Co., Ltd.
Manufacturer and brand owner in Xiantao, Hubei, China. 10 device types, 1 product catalogued, 1 clearance.
Xiantao Sanda Industrial Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Cap, Surgical and 8 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2009.
10device types registered with the FDA
1product
1510(k) clearance
Registration
| Registered name | XIANTAO SANDA INDUSTRIAL CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008048818 |
| FEI number | 3008048818 |
| DUNS | 547087114 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 仙桃市三达实业有限公司 |
|---|---|
| Unified social credit code | 9142900473088731XN |
| Source | NMPA UDI database |
Location
| City | Xiantao |
|---|---|
| Province | Hubei |
| Address | No.46, East Of Huangjin Avenue,Xiantao |
| Postal code | 433000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Coveralls, Protector Gowns, Staff Coats, Scrub Suits | 2009 | 439 |
| Bedding, Disposable, Medical | Class 1 | Medical Nursing PAD | 2023 | 308 |
| Cap, Surgical | Class 1 | Bouffant CAP, Ulti-MED Surgical CAP, Surgical CAP | 2009 | 178 |
| Cover, Shoe, Operating-Room | Class 1 | Shoe cover, Medicom Shoe Covers | 2009 | 176 |
| Handle, Scalpel | Class 1 | Microsurgery Sleeve, Sleeve, Knife Sleeve | 2009 | 29 |
| Mask, Gas, Anesthetic | Class 1 | Surgical CAP, Face mask | 2009 | 71 |
| Mask, Oxygen | Class 1 | Face mask | 2010 | 126 |
| Mask, Surgical | Class 2 | Surgical Face Mask | 2022 | 125 |
| Non-Surgical Gown | Class 1 | Fluid Impervious Gowns, Medicom Isolation Gowns, Isolation gown | 2009 | 318 |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | Class 1 | Nursing Pad | 2013 | 48 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Sanda | FXX | 2 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K222651 | 2022-12-13 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2001 |
|---|---|
| Employees | 500+ |
| Factory area | 60000 |
| Main products | Medical masks, Surgical masks, Protective suits, Isolation gowns, Surgical clothing |
| Certifications | ISO 9001, ISO 13485, CE, FDA 510K, Medical equipment production license |
| Export markets | Multiple countries (Chinese, English, Spanish, German, Japanese website versions) |
| 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.
The manufacturer named here can complete this record.