Shandong Blue Sail Innovation Co Ltd
Manufacturer and brand owner in Weifang, Shandong, China. 1 device type, 1 product catalogued, 3 clearances.
Shandong Blue Sail Innovation Co Ltd is a manufacturer holding a current FDA establishment registration. The registration covers Vinyl Patient Examination Glove. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2010.
1device type
1product
3510(k) clearances
Registration
| Registered name | SHANDONG BLUE SAIL INNOVATION CO LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004150701 |
| FEI number | 3004150701 |
| DUNS | 421258413 |
| Establishment type | Manufacturer |
Location
| City | Weifang |
|---|---|
| Province | Shandong |
| Address | East Side of Xingan Road, |
| Postal code | 262600 |
| Country | China |
What It Makes
| Device type | Class | Listed since | Chinese makers |
|---|---|---|---|
| Vinyl Patient Examination Glove | Class 1 | 2010 | 72 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Blue Sail | LYZ | 2 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K103619 | 2011-08-10 | LYZ | Traditional | This company |
| K102161 | 2010-10-08 | LYZ | Traditional | This company |
| K102160 | 2010-10-04 | LYZ | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Employees | 8962 |
| Main products | Medical gloves, Cardiac stents, Interventional devices, Protective products |
| Certifications | ISO 13485, CE, FDA |
| Export markets | Global |
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.