FDA Registration
Active
🇨🇳 China
SHANDONG XINGYU GLOVES CO., LTD
Reg #: 3013451367
·
FEI: 3013451367
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- SHANDONG XINGYU GLOVES CO., LTD
- Registration Number
- 3013451367
- FEI Number
- 3013451367
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.2158,Yaoqian Road,Economic Development Zone
- City
- Gaomi Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K171616
Owner / Operator
- Firm Name
- Shandong Xingyu gloves Co., Ltd
- Operator Number
- 10064146
- Address
- No.2158,Yaoqian Road,Economic Development Zone
- City
- Gaomi
- State
- Shandong
- Postal Code
- 261502
- Country
- CN
- Correspondent
- GAOYONG HONG
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 |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2020-03-25 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-04-18 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-04-18 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-04-18 |
Proprietary Names
Xingyu Powder Free Nitrile Patient Examination Gloves, Blue Color
Nitrile Disposable Examination Gloves
Xingyu Nitrile Powder Free Patient Examination Gloves, White Color
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device