Xiantao Xinfa Plastic Products Co., Ltd.
Registered establishment in Xiantao, Hubei, China. 8 device types.
Xiantao Xinfa Plastic Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cap, Surgical, Gown, Examination and 6 other device types. Its earliest product listing with the FDA dates from 2007.
Registration
| Registered name | XIANTAO XINFA PLASTIC PRODUCTS Co. LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006538071 |
| FEI number | 3006538071 |
| Establishment type | Contract manufacturer, Private-label distributor, Manufacturer |
Chinese Registration
| Chinese legal name | 仙桃新发塑料制品有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Xiantao |
|---|---|
| Province | Hubei |
| Address | Zhongling Industrial Park |
| Postal code | 433018 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | 2007 | 439 | |
| Bedding, Disposable, Medical | Class 1 | 2014 | 308 | |
| Cap, Surgical | Class 1 | Cap, Surgical | 2008 | 178 |
| Cover, Shoe, Operating-Room | Class 1 | 2008 | 176 | |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | 2020 | 182 | |
| Gown, Examination | Class 1 | 2015 | 109 | |
| Gown, Isolation, Surgical | Class 2 | 2017 | 21 | |
| Non-Surgical Gown | Class 1 | 2008 | 318 |
Clearances
No clearance names Xiantao Xinfa Plastic Products Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K160471 | 2017-01-31 | FYC | Traditional | Medline Industries, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1992 |
|---|---|
| Employees | 4,000+ |
| Factory area | 125,800 m² |
| Main products | SMMS non-woven fabric, Protective clothing, Operating clothes, Shoe covers, Round hats |
| Certifications | Hubei demonstration enterprise of high-tech transformation, Hubei trustworthy enterprise, Hubei new and high-tech enterprise |
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.