Data / Medical devices / Vietnam / Basic International Viet Nam Co.,ltd
Basic International Viet Nam Co.,ltd: FDA-registered device maker in QUANG TRUNG WARD Thanh Hoa, Vietnam, 4 510(k) clearances
Basic International Viet Nam Co.,ltd is registered with the FDA (registration 3038276166) in QUANG TRUNG WARD Thanh Hoa, Vietnam. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 27, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3038276166
- Address
- Lot CN - 04 Northern Zone A, Bim Son Industrial Park, Quang Trung Ward, QUANG TRUNG WARD Thanh Hoa, Vietnam, 440000
- Owner or operator
- BASIC INTERNATIONAL VIET NAM CO.,LTD (10093303)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 26, 2025
- Registered through
- 2026
- Brand names listed
- Disposable Nitrile gloves, Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs blue, Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 27, 2025 | K251716 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | LZA | Substantially Equivalent | Basic Medical Technology, Inc. | accessdata.fda.gov |
| February 18, 2025 | K243792 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White) | LZA | Substantially Equivalent | Basic Medical Technology, Inc. | accessdata.fda.gov |
| January 31, 2025 | K243441 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) | LZA | Substantially Equivalent | Basic Medical Technology, Inc. | accessdata.fda.gov |
| March 22, 2024 | K231938 | Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Updated August 27, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.