Hubei Haixin Protective Products Group Co., Ltd.
Manufacturer and brand owner in Songzi, Hubei, China. 10 device types, 1 product catalogued.
Hubei Haixin Protective Products Group Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cap, Surgical, Mask, 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 2006.
Registration
| Registered name | Hubei Haixin Protective Products Group Co.,Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004158259 |
| FEI number | 3004158259 |
| DUNS | 530030865 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Songzi |
|---|---|
| Province | Hubei |
| Address | Jinsong Avenue 8-8,Chengdong Industrial Zone |
| Postal code | 434205 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Face Shield | 2008 | 439 |
| Cap, Surgical | Class 1 | Bouffant Cap | 2006 | 178 |
| Cover, Mattress (Medical Purposes) | Class 1 | CPE Mattress Cover,pp Mattress Cover | 2008 | 89 |
| Cover, Shoe, Operating-Room | Class 1 | 2011 | 176 | |
| Gown, Examination | Class 1 | Isolation Gown | 2006 | 109 |
| Gown, Isolation, Surgical | Class 2 | AAMI 3 Fld Resist Surgical Isolation Gown | 2020 | 21 |
| Mask, Surgical | Class 2 | Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80), Earloop Procedure Mask | 2013 | 125 |
| Non-Surgical Gown | Class 1 | Cover Gown; Coverall; Impervious Gown; Isolation Gown; Lab Coat; Lab Jacket; Thumbloop Gown, Non-surgical isolation gown | 2008 | 318 |
| Respirator, Surgical | Class 2 | Respiratory Mask | 2022 | 118 |
| Suit, Surgical | Class 1 | Suit Surgical | 2011 | 74 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Green Cross | FXX | 1 |
Clearances
No clearance names Hubei Haixin Protective Products Group Co., Ltd. as applicant. 3 are held by other companies 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 |
|---|---|---|---|---|
| K222266 | 2022-09-26 | FXX | Traditional | Jingzhou Haixin Green Cross Medical Products Co., Ltd. |
| K171535 | 2018-02-15 | FYC | Traditional | Jingzhou Haixin Green Cross Medical Products Co., Ltd. |
| K123787 | 2013-07-17 | FXX | Traditional | Jingzhou Haixin Green Cross Medical Products Co.,L |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1994 |
|---|---|
| Employees | 1050 |
| Factory area | 30000 square meters |
| Main products | Surgical gowns, Isolation gowns, Disposable masks, Protective coveralls, Headwear |
| Certifications | ISO9001, ISO13485, CE, FDA |
| Export markets | European Union, United States, Canada |
| OEM and ODM | Offered |
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.