Hubei Wanli Protective Products Co., Ltd.
Manufacturer and brand owner in Xiantao, Hubei, China. 15 device types, 1 product catalogued, 3 clearances.
Hubei Wanli Protective Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Sling, Arm, Sheet, Burn and 13 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2011.
15device types registered with the FDA
1product
3510(k) clearances
Registration
| Registered name | HUBEI WANLI PROTECTIVE PRODUCTS CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008770063 |
| FEI number | 3008770063 |
| DUNS | 527797615 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 湖北万里防护用品有限公司 |
|---|---|
| Unified social credit code | 914290047932677241 |
| Source | NMPA UDI database |
Location
| City | Xiantao |
|---|---|
| Province | Hubei |
| Address | NO.106 West Station Huangjin Road |
| Postal code | 433000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Non woven coverall, Microporous coverall, PP+PE coverall, DISPOSABLE COVERALL, SMS coverall, Apron, PP+PE coverall, Microporous coverall, Non woven coverall, Disposable Coverall, SMS coverall | 2011 | 439 |
| Bedding, Disposable, Medical | Class 1 | Stretcher sheets drape, NON WOVEN SHEETS, Equipment cover, Cot Sheet, CPE SHEETS, SMS SHEETS, DISPOSABLE BED SHEETS, PP+PE SHEETS, | 2011 | 308 |
| Cap, Surgical | Class 1 | Disposable CAP, PE CAP, Clip CAP, NON Woven CAP, Bouffant CAP, Nylon CAP and 1 more | 2011 | 178 |
| Cover, Shoe, Operating-Room | Class 1 | Disposable Shoe Cover, DISPOSABLE SHOE COVER, Sleeve Cover | 2011 | 176 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Face Mask | 2020 | 182 |
| Gown, Surgical | Class 2 | Surgical Gown | 2023 | 68 |
| Mask, Scavenging | Class 1 | Disposbale Face Mask, Paper Mask, Dust Mask | 2011 | 158 |
| Mask, Surgical | Class 2 | Disposable Medical mask, Disposable medical mask (with bandage), Disposable Medical Mask | 2021 | 125 |
| Non-Surgical Gown | Class 1 | LAB COAT, DISPOSABLE non-SURGICAL GOWN, Disposable Pants, Disposable BP Cuff Sleeve Barrier, Lab Coat, SAUNA CLOTHES,, Patient exam gown, Disposable Suit | 2011 | 318 |
| Respirator, Surgical | Class 2 | KN95 Protective Mask, TMKN95, CHKN95, WLM2013, WLM-2009 | 2021 | 118 |
| Sheet, Burn | Class 1 | Burn Sheet | 2011 | 20 |
| Sling, Arm | Class 1 | Triangular Bandage | 2015 | 126 |
| Stethoscope, Manual | Class 1 | 2017 | 64 | |
| Strap, Head, Gas Mask | Class 1 | 2014 | 29 | |
| Tourniquet, Nonpneumatic | Class 1 | 2017 | 124 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Xian Wanli | FXX | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K214085 | 2022-04-06 | FXX | Traditional | This company |
| K211509 | 2021-10-24 | FYA | Traditional | This company |
| K210150 | 2021-06-02 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1998 |
|---|---|
| Employees | 700+ |
| Factory area | 150,000 m² |
| Main products | disposable coveralls, surgical gowns, isolation gowns, face masks, nonwoven fabrics |
| Certifications | ISO 13485, ISO 9001, ISO 14001, EU CE, GRS, UK BSI, Sedex |
| Export markets | >100 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.
The manufacturer named here can complete this record.