FDA Registration
Active
🇨🇳 China
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
Reg #: 3018779144
·
FEI: 3018779144
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- XINGYU MEDICAL TECH CO.,LTD
- Registration Number
- 3018779144
- FEI Number
- 3018779144
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.2189 Yaoqian Road, Gaomi Economic Development Zone
- City
- Weifang Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K240629
Owner / Operator
- Firm Name
- Xingyu Medical Tech Co.,Ltd
- Operator Number
- 10081106
- Address
- No.2189 Yaoqian Road, Gaomi Economic Development Zone
- City
- Weifang
- State
- Shandong
- Postal Code
- 261500
- Country
- CN
- Correspondent
- Chongyu Xu
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-08-14 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-08-14 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-08-14 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-08-14 |
Proprietary Names
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device