Data / Medical devices / China / Xingyu Medical Tech Co.,ltd
Xingyu Medical Tech Co.,ltd: FDA-registered device maker in Weifang City Shandong, China, 3 510(k) clearances
Xingyu Medical Tech Co.,ltd is registered with the FDA (registration 3018779144) in Weifang City Shandong, China. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 28, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018779144
- Address
- No.2189 Yaoqian Road, Gaomi Economic Development Zone, Weifang City Shandong, China, 261500
- Owner or operator
- Xingyu Medical Tech Co.,Ltd (10081106)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- March 17, 2021
- Registered through
- 2026
- Brand names listed
- Nitrile Disposable Examination Gloves, Nitrile Disposable Examination Gloves (Tested For Use With Chemotherapy Drugs), Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl, Nitrile Disposable Examination Gloves-510K, Xingyu Nitrile Powder Free Patient Examination Gloves, White Color, Xingyu Powder Free Nitrile Patient Examination Gloves, Blue Color
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| 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 May 28, 2024. 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.