FDA Registration
Active
🇲🇾 Malaysia
TRU FIP'M POWDER FREE NITRILE EXAMINATION GLOVES
Reg #: 3020763216
·
FEI: 3020763216
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- KGM GLOVES SDN. BHD.
- Registration Number
- 3020763216
- FEI Number
- 3020763216
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- LOT 18893 & 18894, JALAN PERUSAHAAN 9, KAWASAN PERUSAHAAN KAMUNTING
- City
- KAMUNTING Perak
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K220284
Owner / Operator
- Firm Name
- KGM GLOVES SDN. BHD.
- Operator Number
- 10082891
- Address
- LOT 18893 & 18894, JALAN PERUSAHAAN 9, KAWASAN PERUSAHAAN KAMUNTING
- City
- KAMUNTING
- State
- Perak
- Postal Code
- 34600
- Country
- MY
US Agent
- Business Name
- FDAbasics LLC
- Contact Name
- Jerry Doane
- Address
- 15815 SW 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2022-07-13 |
Proprietary Names
TRU FIP'M POWDER FREE NITRILE EXAMINATION GLOVES
Establishment Types
Manufacture Medical Device