FDA Registration
Active
🇲🇾 Malaysia
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simula
Reg #: 3019252794
·
FEI: 3019252794
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ONETEXX SDN BHD
- Registration Number
- 3019252794
- FEI Number
- 3019252794
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No: 73 - 86, Jalan Logam 5, Perindustrian Kamunting 3,, Kamunting Raya Industrial Park
- City
- Kamunting Perak
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K221773
Owner / Operator
- Firm Name
- Onetexx Sdn Bhd
- Operator Number
- 10081868
- Address
- No: 73 - 86, Jalan Logam 5, Perindustrian Kamunting 3,, Kamunting Raya Industrial Park
- City
- Kamunting
- State
- Perak
- Postal Code
- 34600
- Country
- MY
- Correspondent
- Freddy Low
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 |
|---|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2022-07-31 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2022-07-31 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2022-07-31 |
Proprietary Names
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simula
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)