Data / Medical devices / China / Zibo Blue Sail Health Technology Co., Ltd
Zibo Blue Sail Health Technology Co., Ltd: FDA-registered device maker in Zibo Shandong, China, 2 510(k) clearances
Zibo Blue Sail Health Technology Co., Ltd is registered with the FDA (registration 3023272672) in Zibo Shandong, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 16, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3023272672
- Address
- No.1888 Honghua Road High Technical Area, Zibo Shandong, China, 255400
- Owner or operator
- Zibo Blue Sail Health Technology Co., Ltd (10085116)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- May 6, 2022
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 16, 2022 | K221229 | Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves | LZA | Substantially Equivalent | Zibo Blue Sail Health Technology Co., Ltd. | accessdata.fda.gov |
| March 22, 2019 | K182554 | Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | He Chuang Plastic & Rubber Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Latex Patient Examination Glove
Updated July 16, 2022. 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.