Data / Medical devices / Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs / Indonesia
FDA-registered makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs in Indonesia: 9 establishments
9 establishments in Indonesia are registered with the FDA to make Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs (product code OPJ). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- Product code
- OPJ
- Country
- Indonesia
Makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs in Indonesia
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| PT Basic International Sumatera | Simalungun Regency Sumatera Utara, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT Greatview Technologies | Simalungun Sumatera Utara, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT Healthguard Technologies | Simalungun Sumatera Utara, Indonesia | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT K-Tech Industries | Simalungun Sumatera Utara, Indonesia | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT Newpoint Technology | Simalungun Sumatera Utara, Indonesia | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT Ywanjan Technology | Pelalawan Regency Riau, Indonesia | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT. Medisafe Technologies | Kab. Deli Serdang Sumatera Utara, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT. Sintong Unigolden Glove | KISARAN Sumatera Utara, Indonesia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pt.shamrock Manufacturing Corp. | MEDAN Sumatera Utara, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.