Shandong Blue Sail Health Technology Co., Ltd.
Registered establishment in Weifang, Shandong, China. 3 device types, 1 clearance.
Shandong Blue Sail Health Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Medical Glove, Specialty, Polymer Patient Examination Glove and 1 other device type. Its earliest product listing with the FDA dates from 2022.
3device types registered with the FDA
1510(k) clearance
Registration
| Registered name | SHANDONG BLUE SAIL HEALTH TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3022543478 |
| FEI number | 3022543478 |
| Establishment type | Manufacturer |
Location
| City | Weifang |
|---|---|
| Province | Shandong |
| Address | No.1888 Longshan Road, |
| Postal code | 262600 |
| Country | China |
What It Makes
| Device type | Class | Listed since | Chinese makers |
|---|---|---|---|
| Medical Glove, Specialty | Class 1 | 2022 | 48 |
| Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs | Class 1 | 2022 | 32 |
| Polymer Patient Examination Glove | Class 1 | 2022 | 83 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K220228 | 2022-03-18 | LZA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Nitrile Gloves, Vinyl Gloves, Latex Gloves, Disposable Face Masks, Medical Dressings |
|---|---|
| Certifications | FDA registration, Health Canada approval (vinyl, nitrile), EN 455, EN 374 |
| Export markets | USA, Canada, Europe |
| OEM and ODM | Offered |
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.
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