Data / Medical devices / Indonesia / PT Newpoint Technology
PT Newpoint Technology: FDA-registered device maker in Simalungun Sumatera Utara, Indonesia, 4 510(k) clearances
PT Newpoint Technology is registered with the FDA (registration 3036774599) in Simalungun Sumatera Utara, Indonesia. 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 2, 2026.
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- FDA registration number
- 3036774599
- Address
- Surfaktan Road Kavling E17, Sei Mangkei, Kec. Bosar Maligas, Kab., Simalungun Sumatera Utara, Indonesia, 21183
- Owner or operator
- PT NewPoint Technology (10092673)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- February 4, 2025
- Registered through
- 2026
- Brand names listed
- Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, 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, Patient Nitrile Examination Gloves, Powder Free, Non-Sterile
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, 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 |
| 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 |
Compare with other makers
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
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.