Zibo Blue Sail Health Technology Co., Ltd.
Registered establishment in Zibo, Shandong, China. 3 device types, 1 clearance.
Zibo Blue Sail Health Technology Co., Ltd. is a specification developer holding a current FDA establishment registration. The registration covers Medical Glove, Specialty, Latex Patient Examination Glove and 1 other device type. Its earliest product listing with the FDA dates from 2022.
Registration
| Registered name | ZIBO BLUE SAIL HEALTH TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3023272672 |
| FEI number | 3023272672 |
| Establishment type | Specification developer, Manufacturer, Exporter |
Location
| City | Zibo |
|---|---|
| Province | Shandong |
| Address | No.1888 Honghua Road |
| Postal code | 255400 |
| Country | China |
What It Makes
| Device type | Class | Listed since | Chinese makers |
|---|---|---|---|
| Latex Patient Examination Glove | Class 1 | 2022 | 12 |
| Medical Glove, Specialty | Class 1 | 2022 | 48 |
| Polymer Patient Examination Glove | Class 1 | 2022 | 83 |
Clearances
1 clearance names Zibo Blue Sail Health Technology Co., Ltd. as applicant. 1 is held by another company 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 |
|---|---|---|---|---|
| K221229 | 2022-07-16 | LZA | Traditional | This company |
| K182554 | 2019-03-22 | LZA | Traditional | HE Chuang Plastic & Rubber Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Employees | 5000+ |
| Main products | Medical protective gloves, Cardiac stents, Endoscopic staplers, Ultrasonic scalpels |
| Export markets | 130+ countries |
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.