FDA Registration
Active
🇮🇩 Indonesia
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate
Reg #: 3038187456
·
FEI: 3038187456
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- PT HEALTHGUARD TECHNOLOGIES
- Registration Number
- 3038187456
- FEI Number
- 3038187456
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Jalan Surfaktan Kavling D17, KEK Sei Mangkei, Desa/Kelurahan Sei Mangkei, Kec. Bosar Maligas, Kab.
- City
- Simalungun Sumatera Utara
- Country
- ID
Regulatory Submissions
- 510(k) Number
- K243792
Owner / Operator
- Firm Name
- PT HealthGuard Technologies
- Operator Number
- 10093198
- Address
- Jalan Surfaktan Kavling D17, KEK Sei Mangkei, Desa/Kelurahan Sei Mangkei, Kec. Bosar Maligas, Kab.
- City
- Simalungun
- State
- Sumatera Utara
- Postal Code
- 21182
- Country
- ID
- Correspondent
- Benjamin Wilson
US Agent
- Business Name
- Primemax
- Contact Name
- Max Lee
- Address
- 805 BARRINGTON AVE.
- City
- Ontario
- State
- CA
- ZIP
- 91764
- Country
- US
- [email protected]
- Phone
- 909 9801678
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2025-04-13 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2025-04-13 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-04-13 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2025-04-13 |
Proprietary Names
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device