FDA Registration
Active
🇲🇾 Malaysia
Latex Powder Free Examination Glove
Reg #: 3018167658
·
FEI: 3018167658
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- KL-KEPONG RUBBER PRODUCTS SDN. BHD.
- Registration Number
- 3018167658
- FEI Number
- 3018167658
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lot 134905, 3/4 Mile Off Jalan Bercham, Kawasan Perindustrian Bercham
- City
- IPOH Perak
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K023866
Owner / Operator
- Firm Name
- Kl-Kepong Rubber Products Sdn. Bhd.
- Operator Number
- 10081041
- Address
- Lot 134905, 3/4 Mile Off Jalan Bercham, Kawasan Perindustrian Bercham
- City
- IPOH
- State
- Perak
- Postal Code
- 31400
- Country
- MY
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2022-01-10 |
Proprietary Names
Latex Powder Free Examination Glove
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)