Data / Medical devices / China / Shandong Xingyu Gloves Co., Ltd
Shandong Xingyu Gloves Co., Ltd: FDA-registered device maker in Gaomi Shandong, China, 3 510(k) clearances
Shandong Xingyu Gloves Co., Ltd is registered with the FDA (registration 3013451367) in Gaomi Shandong, China. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 1, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013451367
- Address
- No.2158,Yaoqian Road,Economic Development Zone, Gaomi Shandong, China, 261502
- Owner or operator
- Shandong Xingyu gloves Co., Ltd (10064146)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- March 25, 2020
- Registered through
- 2026
- Brand names listed
- Nitrile Disposable Examination Gloves, 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 | 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 |
|---|---|---|---|---|---|---|
| April 1, 2024 | K233990 | Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) | LZA | Substantially Equivalent | Shandong Xingyu Gloves Co., Ltd. | accessdata.fda.gov |
| July 31, 2017 | K171615 | Xingyu Nitrile Powder Free Patient Examination Gloves, White color | LZA | Substantially Equivalent | Shandong Xingyu Gloves Co., Ltd. | accessdata.fda.gov |
| July 20, 2017 | K171616 | Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color | LZA | Substantially Equivalent | Shandong Xingyu Gloves Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Updated April 1, 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.