FDA Registration
Active
🇲🇾 Malaysia
Polymer patient examination glove Patient examination glove, specialty Medical gloves with chemotherapy labeling claims
Reg #: 3008509176
·
FEI: 3008509176
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- KOON SENG SDN BHD
- Registration Number
- 3008509176
- FEI Number
- 3008509176
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- PTD16058, Kawasan Perindustrian Tangkak, Jalan Muar
- City
- Tangkak Johor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K220215
Owner / Operator
- Firm Name
- KOON SENG SDN.BHD
- Operator Number
- 8040793
- Address
- PTD 16058, KAWASAN PERINDUSTRIAN TANGKAK, JALAN MUAR
- City
- TANGKAK
- State
- Johor
- Postal Code
- 84900
- Country
- MY
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-07-10 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-07-10 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-07-10 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-07-10 |
Proprietary Names
Polymer patient examination glove Patient examination glove, specialty Medical gloves with chemotherapy labeling claims
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)