Zibo Blue Sail Innovation Co., Ltd.
Manufacturer and brand owner in Zibo, Shandong, China. 3 device types, 2 products catalogued.
Zibo Blue Sail Innovation Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Medical Glove, Specialty, Vinyl Patient Examination Glove and 1 other device type. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
Registration
| Registered name | Zibo Blue Sail Innovation Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009243435 |
| FEI number | 3009243435 |
| DUNS | 621646344 |
| Establishment type | Manufacturer |
Location
| City | Zibo |
|---|---|
| Province | Shandong |
| Address | No. 21 Qingtian Road |
| Postal code | 255414 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Medical Glove, Specialty | Class 1 | 2017 | 48 | |
| Polymer Patient Examination Glove | Class 1 | 2017 | 83 | |
| Vinyl Patient Examination Glove | Class 1 | Blue Sail or Multiple | 2008 | 72 |
Own-Brand Listings
Clearances
No clearance names Zibo Blue Sail Innovation Co., Ltd. as applicant. 4 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 |
|---|---|---|---|---|
| K171782 | 2017-10-12 | LZA | Traditional | Blue Sail Medical Co., Ltd. |
| K163126 | 2017-02-22 | LZA | Traditional | Blue Sail Medical Co., Ltd. |
| K032781 | 2003-11-13 | LYZ | Traditional | Zibo Blue Sail Plastic & Rubber Products Co., Ltd. |
| K032783 | 2003-11-13 | LYZ | Traditional | Zibo Blue Sail Plastic & Rubber Products Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Nitrile gloves, Vinyl gloves, Latex gloves, Disposable face masks, First-aid kits |
|---|---|
| Certifications | FDA, Health Canada, EN 455, EN 374 |
| Export markets | USA, Canada, Europe |
| 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.