FDA Registration
Active
🇲🇾 Malaysia
Powder Free Nitrile Examination Glove - White, Non Sterile
Reg #: 3021233711
·
FEI: 3021233711
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HKL DYNAMICS SDN. BHD. (Formerly known as Hong Seng Gloves Sdn. Bhd.)
- Registration Number
- 3021233711
- FEI Number
- 3021233711
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- LOT 97, JALAN 10, KAWASAN PERUSAHAAN BAKAR ARANG
- City
- SUNGAI PETANI Kedah
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K212802
Owner / Operator
- Firm Name
- HKL DYNAMICS SDN. BHD.
- Operator Number
- 10083806
- Address
- LOT 97, JALAN 10, KAWASAN PERUSAHAAN BAKAR ARANG
- City
- SUNGAI PETANI
- State
- Kedah
- Postal Code
- 08000
- Country
- MY
- Correspondent
- MAGESH RAMANADAN
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2021-12-21 |
Proprietary Names
Powder Free Nitrile Examination Glove - White, Non Sterile
Establishment Types
Manufacture Medical Device