FDA Registration
Active
🇲🇾 Malaysia
Polymer patient examination glove Patient examination glove, specialty Medical gloves with chemotherapy labeling claims
Reg #: 3022407383
·
FEI: 3022407383
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- KSG MEDICARE SDN BHD
- Registration Number
- 3022407383
- FEI Number
- 3022407383
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- PTD 16063 (Lot 15295) Kawasan Perindustrian Tangkak
- City
- Tangkak Johor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K220215
Owner / Operator
- Firm Name
- KSG Medicare Sdn Bhd
- Operator Number
- 10084829
- Address
- PTD 16063 (Lot 15295) Kawasan Perindustrian Tangkak
- City
- Tangkak
- State
- Johor
- Postal Code
- 84900
- Country
- MY
- Correspondent
- Jennifer Yeo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2022-04-05 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2022-04-05 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2022-04-05 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2022-04-05 |
Proprietary Names
Polymer patient examination glove Patient examination glove, specialty Medical gloves with chemotherapy labeling claims
Establishment Types
Manufacture Medical Device