Data / Medical devices / China / Shandong Blue Sail Innovation Co Ltd
Shandong Blue Sail Innovation Co Ltd: FDA-registered device maker in WEIFANG Shandong, China, 3 510(k) clearances
Shandong Blue Sail Innovation Co Ltd is registered with the FDA (registration 3004150701) in WEIFANG Shandong, China. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated August 10, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004150701
- Address
- East Side of Xingan Road, Dongcheng Street Office, Linqu County, WEIFANG Shandong, China, 262600
- Owner or operator
- SHANDONG BLUE SAIL INNOVATION CO LTD (10034242)
- Roles
- Manufacturer
- First device listed
- November 16, 2010
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Vinyl Patient Examination Glove | LYZ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 10, 2011 | K103619 | SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED) | LYZ | Substantially Equivalent | Shandong Blue Sail Innovation Co., Ltd. | accessdata.fda.gov |
| October 8, 2010 | K102161 | BLUE SAIL INNOVATION | LYZ | Substantially Equivalent | Shandong Blue Sail Innovation Co., Ltd. | accessdata.fda.gov |
| October 4, 2010 | K102160 | STRETCH VINYL EXAMINATION GLOVE POWDER FREE | LYZ | Substantially Equivalent | Shandong Blue Sail Innovation Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 10, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.