FDA Registration
Active
🇮🇩 Indonesia
P.T. MAJA AGUNG LATEXINDO
Reg #: 8041150
·
FEI: 3000239897
·
Expires 2026
Products
4
Proprietary Names
4
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- P.T. MAJA AGUNG LATEXINDO
- Registration Number
- 8041150
- FEI Number
- 3000239897
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- JL.UTAMA NO.98 PUJI MULIO
- City
- SUNGGAL DELI SERDANG Sumatera Utara
- Country
- ID
Regulatory Submissions
- 510(k) Number
- K013996
Owner / Operator
- Firm Name
- P.T. MAJA AGUNG LATEXINDO
- Operator Number
- 8041150
- Address
- JL. UTAMA NO. 98 PUJIMULIO, SUNGGAL DELI SERDANG
- City
- SUMATERA UTARA
- State
- ID-SU
- Postal Code
- 20352
- Country
- ID
- Correspondent
- JANE - LAURENCE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2007-12-06 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2007-12-06 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2019-12-13 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-01-13 |
Proprietary Names
Shamrock
Private brands
Polysilk
Powder Free Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)
Establishment Types
Manufacture Medical Device