FDA Registration
Active
🇻🇳 Vietnam
Powder Free Nitrile Examination Gloves (Blue)
Reg #: 3024897455
·
FEI: 3024897455
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED
- Registration Number
- 3024897455
- FEI Number
- 3024897455
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lot CN 05, Viglacera-Phong Dien Industrial Park, Phong Hoa Commune
- City
- Phong Dien Thua Thien-Hue
- Country
- VN
Regulatory Submissions
- 510(k) Number
- K241970
Owner / Operator
- Firm Name
- Kanglongda Vietnam Protection Technology Company Limited
- Operator Number
- 10086425
- Address
- Lot CN 05, Viglacera-Phong Dien Industrial Park, Phong Hoa Commune
- City
- Phong Dien
- State
- Thua Thien-Hue
- Postal Code
- 535041
- Country
- VN
- Correspondent
- Guodong Xuan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-10-17 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-10-17 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-10-17 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-10-17 |
Proprietary Names
Powder Free Nitrile Examination Gloves (Blue)
Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)
Establishment Types
Manufacture Medical Device