Shandong Hysure Safety Tech Co., Ltd.
Registered establishment in Weifang, Shandong, China. 4 device types.
Shandong Hysure Safety Tech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Medical Glove, Specialty, Polymer Patient Examination Glove and 2 other device types. Its earliest product listing with the FDA dates from 2024.
Registration
| Registered name | SHANDONG HYSURE SAFETY TECH CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3031180726 |
| FEI number | 3031180726 |
| Establishment type | Manufacturer, Exporter |
Location
| City | Weifang |
|---|---|
| Province | Shandong |
| Address | Room 1201, Building 1, Heping Square, No. 3555 Heping Road |
| Postal code | 261021 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | Class 1 | Nitrile Disposable Examination Gloves, Tested forUse with Chemotherapy Drugs and Fentanyl | 2026 | 29 |
| Medical Glove, Specialty | Class 1 | Nitrile Disposable Examination Gloves, Tested forUse with Chemotherapy Drugs and Fentanyl, polymer patient examination glove | 2024 | 48 |
| Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs | Class 1 | Nitrile Disposable Examination Gloves, Tested forUse with Chemotherapy Drugs and Fentanyl | 2026 | 32 |
| Polymer Patient Examination Glove | Class 1 | Nitrile Disposable Examination Gloves, Tested forUse with Chemotherapy Drugs and Fentanyl, Nitrile Disposable Examination Gloves, polymer patient examination glove | 2024 | 83 |
Clearances
No clearance names Shandong Hysure Safety Tech Co., Ltd. as applicant. 4 are held by other companies 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 |
|---|---|---|---|---|
| K260806 | 2026-06-03 | LZA | Traditional | Vista Industries, LLC. |
| K240629 | 2024-05-28 | LZA | Traditional | Xingyu Medical Tech Co., Ltd. |
| K212735 | 2022-01-11 | LZA | Traditional | Xingyu Medical Tech Co., Ltd. |
| K212578 | 2021-12-02 | LZA | Traditional | Xingyu Medical Tech Co., Ltd. |
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.