Data / Medical devices / China / Shandong Hysure Safety Tech Co., Ltd
Shandong Hysure Safety Tech Co., Ltd: FDA-registered device maker in Weifang City Shandong, China, 4 510(k) clearances
Shandong Hysure Safety Tech Co., Ltd is registered with the FDA (registration 3031180726) in Weifang City Shandong, China. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 3, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3031180726
- Address
- Room 1201, Building 1, Heping Square, No. 3555 Heping Road, Weifang City Shandong, China, 261021
- Owner or operator
- Shandong Hysure Safety Tech Co., Ltd (10090339)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- March 14, 2024
- Registered through
- 2026
- Brand names listed
- Nitrile Disposable Examination Gloves, Nitrile Disposable Examination Gloves, Tested forUse with Chemotherapy Drugs and Fentanyl, polymer patient examination glove
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| June 3, 2026 | K260806 | Nitrile Disposable Examination Gloves | LZA | Substantially Equivalent | Vista Industries,, LLC | accessdata.fda.gov |
| May 28, 2024 | K240629 | Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl | LZA | Substantially Equivalent | Xingyu Medical Tech Co., Ltd. | accessdata.fda.gov |
| January 11, 2022 | K212735 | Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) | LZA | Substantially Equivalent | Xingyu Medical Tech Co., Ltd. | accessdata.fda.gov |
| December 2, 2021 | K212578 | Nitrile disposable examination gloves | LZA | Substantially Equivalent | Xingyu Medical Tech 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 Fentanyl And Other Opioid Protection Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Updated June 3, 2026. 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.