FDA Registration
Active
🇲🇾 Malaysia
KOON SENG SDN BHD
Reg #: 3008509176
·
FEI: 3008509176
·
Expires 2026
Products
5
Proprietary Names
8
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- KOON SENG SDN BHD
- Registration Number
- 3008509176
- FEI Number
- 3008509176
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- PTD16058, Kawasan Perindustrian Tangkak, Jalan Muar
- City
- Tangkak Johor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K110960
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 | 2011-07-15 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2018-05-16 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2021-12-28 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2021-12-28 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2008-10-20 |
Proprietary Names
Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue
KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)
Polymer patient examination glove Patient examination glove, specialty Medical gloves with chemotherapy labeling claims
ROYAL IMEPRIAL Powdered Latex Examination Gloves with Protein Control Labeling Claim (200 Micrograms or Less)
KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE
Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citra
Royal Imperial Powder Free Polymer Coated Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)