Data / Medical devices / China / Zibo Blue Sail Innovation Co., Ltd
Zibo Blue Sail Innovation Co., Ltd: FDA-registered device maker in Zibo Shandong, China, 4 510(k) clearances
Zibo Blue Sail Innovation Co., Ltd is registered with the FDA (registration 3009243435) in Zibo Shandong, China. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 12, 2017. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3009243435
- Address
- No. 21 Qingtian Road Qilu Chemical Industrial Park, Zibo Shandong, China, 255414
- Owner or operator
- Zibo Blue Sail Innovation Co., Ltd (10027479)
- Roles
- Manufacturer
- First device listed
- November 11, 2008
- Registered through
- 2026
- Brand names listed
- Blue Sail or Multiple
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| October 12, 2017 | K171782 | Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs | LZA | Substantially Equivalent | Blue Sail Medical Co.,Ltd | accessdata.fda.gov |
| February 22, 2017 | K163126 | Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) | LZA | Substantially Equivalent | Blue Sail Medical Co.,Ltd | accessdata.fda.gov |
| November 13, 2003 | K032783 | BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Zibo Blue Sail Plastic & Rubber Products Co., Ltd. | accessdata.fda.gov |
| November 13, 2003 | K032781 | BLUE SAIL (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Zibo Blue Sail Plastic & Rubber Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Vinyl Patient Examination Glove
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
Updated October 12, 2017. 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.