FDA Registration
Active
🇨🇳 China
Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentany
Reg #: 3016245346
·
FEI: 3016245346
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- DESEN MEDICAL PRODUCTS CO.,LTD.
- Registration Number
- 3016245346
- FEI Number
- 3016245346
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Chuangxin Road, West Industrial Park
- City
- Tangshan Hebei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K231029
Owner / Operator
- Firm Name
- Desen Medical Products Co.,Ltd.
- Operator Number
- 10062154
- Address
- Chuangxin Road, West Industrial Park
- City
- Tangshan
- 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 |
| 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 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-03-19 |
Proprietary Names
Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentany
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device