FDA Registration
Active
🇨🇳 China
Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs
Reg #: 3009335895
·
FEI: 3009335895
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- TANGSHAN KAIYUE GLOVE CO LTD
- Registration Number
- 3009335895
- FEI Number
- 3009335895
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- TANGLE ROAD , LUANNAN COUNTY
- City
- TANG SHAN Hebei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K230662
Owner / Operator
- Firm Name
- TANGSHAN KAIYUE GLOVE CO LTD
- Operator Number
- 10037326
- Address
- TANGLE ROAD , LUANNAN COUNTY
- City
- TANG SHAN
- State
- Hebei
- Postal Code
- 063500
- Country
- CN
- Correspondent
- Alicia li
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-03-19 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-03-19 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-03-19 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-03-19 |
Proprietary Names
Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device