FDA Registration
Active
🇲🇾 Malaysia
WEAR SAFE (MALAYSIA) SDN BHD
Reg #: 3010602489
·
FEI: 3010602489
·
Expires 2026
Products
6
Proprietary Names
0
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- WEAR SAFE (MALAYSIA) SDN BHD
- Registration Number
- 3010602489
- FEI Number
- 3010602489
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LOT 5068 & 5069, BATU 4 ½, JALAN MERU,
- City
- KLANG Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K090066
Owner / Operator
- Firm Name
- WEAR SAFE (MALAYSIA) SDN BHD
- Operator Number
- 9066807
- Address
- LOT 13726,JALAN HAJI SALLEH, BATU 5 1/4,, OFF JALAN MERU, KLANG, SELANGOR, 41050,
- City
- KLANG
- State
- Selangor
- Postal Code
- 41050
- Country
- MY
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 |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2019-11-26 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2019-11-26 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2019-11-26 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2015-05-20 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2012-09-26 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-08-24 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device