Shandong Xingyu Gloves Co., Ltd.
Registered establishment in Gaomi, Shandong, China. 4 device types, 4 clearances.
Shandong Xingyu Gloves 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 2020.
4device types registered with the FDA
4510(k) clearances
Registration
| Registered name | SHANDONG XINGYU GLOVES CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013451367 |
| FEI number | 3013451367 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 山东星宇手套有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Gaomi |
|---|---|
| Province | Shandong |
| Address | No.2158,Yaoqian Road,Economic Development Zone |
| Postal code | 261502 |
| 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 | 2024 | 29 |
| Medical Glove, Specialty | Class 1 | Nitrile Disposable Examination Gloves | 2024 | 48 |
| Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs | Class 1 | Nitrile Disposable Examination Gloves | 2024 | 32 |
| Polymer Patient Examination Glove | Class 1 | Xingyu Powder Free Nitrile Patient Examination Gloves, Blue Color, Nitrile Disposable Examination Gloves, Xingyu Nitrile Powder Free Patient Examination Gloves, White Color | 2020 | 83 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K233990 | 2024-04-01 | LZA | Traditional | This company |
| K221272 | 2022-06-28 | FXX | Traditional | This company |
| K171615 | 2017-07-31 | LZA | Traditional | This company |
| K171616 | 2017-07-20 | LZA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1992 |
|---|---|
| Employees | 5000+ |
| Factory area | 533000 ㎡ |
| Main products | Cut resistance gloves, Impact resistance gloves, Chemical resistance gloves, Safety gloves, Protective gloves |
| Certifications | ISO 9001, ISO 14001, CE |
| Export markets | Over 120 countries including EU, United States, Russia, Japan, Australia, Canada, Mexico, Brazil |
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.