FDA Registration
Active
🇲🇾 Malaysia
KOSSAN LATEX INDUSTRIES (M) SDN BHD
Reg #: 3005632797
·
FEI: 3005632797
·
Expires 2026
Products
5
Proprietary Names
0
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- KOSSAN LATEX INDUSTRIES (M) SDN BHD
- Registration Number
- 3005632797
- FEI Number
- 3005632797
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LOT 6129,JALAN HAJI ABDUL MANAN, Batu 5 1/4, JALAN MERU
- City
- KLANG Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K060771
Owner / Operator
- Firm Name
- KOSSAN LATEX INDUSTRIES (M) SDN. BHD.
- Operator Number
- 8040735
- Address
- LOT 16632, 5 1/4 MILES,, JALAN MERU
- City
- KLANG
- State
- Selangor
- Postal Code
- 41050
- Country
- MY
- Correspondent
- LIM - KWAN HWA
US Agent
- Business Name
- Parexel International
- Contact Name
- Avani Patel
- Address
- 541 Church At North Hills St
- City
- Raleigh
- State
- NC
- ZIP
- 27609
- Country
- US
- [email protected]
- Phone
- 978 4358575
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2016-09-12 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2016-09-12 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2012-05-28 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2026-06-18 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2022-01-23 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device