Data / Medical devices / Indonesia / PT Basic International Sumatera
PT Basic International Sumatera: FDA-registered device maker in Simalungun Regency Sumatera Utara, Indonesia, 3 510(k) clearances
PT Basic International Sumatera is registered with the FDA (registration 3038284237) in Simalungun Regency Sumatera Utara, Indonesia. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 27, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038284237
- Address
- Surfactant Road, Land Parcels D9 - D16, C8 - C15, C16 (half) - C24, Sei Mangkei Economic Zone Sei Mangkei Village / Sub - District, Bosar Maligas District, Simalungun Regency Sumatera Utara, Indonesia, 21183
- Owner or operator
- PT BASIC INTERNATIONAL SUMATERA (10093302)
- 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, Opioid Fentanyl Citrate, Simulated Gastric, Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs pink, Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid
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 |
| July 9, 2025 | K250193 | Nitrile Powder-Free Exam Gloves 2.8, 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 |
| 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 |
Compare with other makers
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
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.