FDA Registration
Active
🇨🇳 China
Powder Free Nitrile Examination Glove , Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl
Reg #: 3028162329
·
FEI: 3028162329
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO LTD.
- Registration Number
- 3028162329
- FEI Number
- 3028162329
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 41 Shuangshan Road, Boshan District
- City
- Zibo Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K233598
Owner / Operator
- Firm Name
- Xinwei (Shandong) Plastic and Rubber Products Co Ltd.
- Operator Number
- 10088635
- Address
- 41 Shuangshan Road, Boshan District
- City
- Zibo
- State
- Shandong
- Postal Code
- 255000
- Country
- CN
- Correspondent
- MAX LI
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-08-07 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-08-07 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-08-07 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-08-07 |
Proprietary Names
Powder Free Nitrile Examination Glove , Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)