Data / Medical devices / China / Shandong Blue Sail Health Technology Co., Ltd
Shandong Blue Sail Health Technology Co., Ltd: FDA-registered device maker in Weifang Shandong, China, 1 510(k) clearance
Shandong Blue Sail Health Technology Co., Ltd is registered with the FDA (registration 3022543478) in Weifang Shandong, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 18, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3022543478
- Address
- No.1888 Longshan Road, Longshan Advanced Technology Industry Park, Linqu County, Weifang Shandong, China, 262600
- Owner or operator
- Shandong Blue Sail Health Technology Co., Ltd (10084666)
- Roles
- Manufacturer
- First device listed
- March 20, 2022
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 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 |
|---|---|---|---|---|---|---|
| March 18, 2022 | K220228 | Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs | LZA | Substantially Equivalent | Shandong Blue Sail Health Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
Updated March 18, 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.