FDA Registration
Active
🇨🇳 China
Nitrile Medical Glove
Reg #: 3015422337
·
FEI: 3015422337
·
Expires 2025
Products
4
Proprietary Names
3
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- XIAMEN FIRSTCARE IMP. & EXP. CO.,LTD.
- Registration Number
- 3015422337
- FEI Number
- 3015422337
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 602-1, Bldg. 2A, Torch Xinke Plaza, No.2 Weili Road
- City
- Xiamen Fujian
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K233598
Owner / Operator
- Firm Name
- Xiamen FirstCare Imp. & Exp. Co.,ltd.
- Operator Number
- 10062096
- Address
- 602, No.786, East Lian Qian Road, Siming District
- City
- Xiamen
- State
- Fujian
- Postal Code
- 361000
- Country
- CN
- Correspondent
- QINGHONG GU
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2025-03-06 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2025-03-06 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2025-03-06 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-03-06 |
Proprietary Names
Nitrile Medical Glove
Polymer Patient Examination Glove
Nitrile Patient Examination Glove
Establishment Types
Export Device to the United States But Perform No Other Operation on Device