FDA Registration
Active
🇨🇳 China
Polymer patient examination glove
Reg #: 3014345238
·
FEI: 3014345238
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- OPUS GLOVES CO.,LTD.
- Registration Number
- 3014345238
- FEI Number
- 3014345238
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 288 juchen rd, jiading
- City
- shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K230662
Owner / Operator
- Firm Name
- opus gloves co.,ltd.
- Operator Number
- 10057196
- Address
- 288 juchen rd, jiading
- City
- shanghai
- State
- Hebei
- Postal Code
- 201821
- Country
- CN
- Correspondent
- Alicia li
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-12-18 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-12-18 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-12-18 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-12-18 |
Proprietary Names
Polymer patient examination glove
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)