FDA Registration
Active
🇮🇩 Indonesia
PT K-TECH INDUSTRIES
Reg #: 3038187455
·
FEI: 3038187455
·
Expires 2026
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- PT K-TECH INDUSTRIES
- Registration Number
- 3038187455
- FEI Number
- 3038187455
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Jalan Surfaktan Kavling D19, KEK Sei Mangkei, Desa/Kelurahan Sei Mangkei, Kec. Bosar Maligas, Kab.
- City
- Simalungun Sumatera Utara
- Country
- ID
Regulatory Submissions
- 510(k) Number
- K243441
Owner / Operator
- Firm Name
- PT K-Tech Industries
- Operator Number
- 10093197
- Address
- Jalan Surfaktan Kavling D19, KEK Sei Mangkei, Desa/Kelurahan Sei Mangkei, Kec. Bosar Maligas, Kab.
- City
- Simalungun
- State
- Sumatera Utara
- Postal Code
- 21183
- Country
- ID
- Correspondent
- Aditya Pratama
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2025-11-20 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-11-20 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2025-11-20 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2025-11-20 |
Proprietary Names
Nitrile Powder-Free Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate
Establishment Types
Manufacture Medical Device