FDA Registration
Active
🇲🇾 Malaysia
Polymer Coated Latex Medical
Reg #: 9617445
·
FEI: 3860
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- QUALITY LATEX PRODUCTS MALAYSIA SDN BHD
- Registration Number
- 9617445
- FEI Number
- 3860
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 18 & 20, JALAN KILANG 2, JELAPANG LIGHT INDUST. ESTATE
- City
- IPOH Perak
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K011995
Owner / Operator
- Firm Name
- Quality Latex Products Malaysia Sdn. Bhd.
- Operator Number
- 9033001
- Address
- 18 & 20, Jalan Kilang 2,, Jelapang Light Industrial Estate
- City
- Ipoh, Perak
- State
- MY-08
- Postal Code
- 30100
- Country
- MY
US Agent
- Business Name
- Medapproval LLC
- Contact Name
- William Slevin
- Address
- 11555 Medlock Bridge Rd Ste 100
- City
- Johns Creek
- State
- GA
- ZIP
- 30097
- Country
- US
- [email protected]
- Phone
- 404 5935005
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2008-06-06 |
Proprietary Names
Polymer Coated Latex Medical
Examination Gloves
Establishment Types
Manufacture Medical Device