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Data / Medical devices / Fentanyl And Other Opioid Protection Glove / Indonesia

FDA-registered makers of Fentanyl And Other Opioid Protection Glove in Indonesia: 9 establishments

9 establishments in Indonesia are registered with the FDA to make Fentanyl And Other Opioid Protection Glove (product code QDO). 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
Fentanyl And Other Opioid Protection Glove
Product code
QDO
Country
Indonesia

Makers of Fentanyl And Other Opioid Protection Glove in Indonesia

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
PT Basic International SumateraSimalungun Regency Sumatera Utara, IndonesiaManufacturer0000api.fda.gov
PT Greatview TechnologiesSimalungun Sumatera Utara, IndonesiaManufacturer0000api.fda.gov
PT Healthguard TechnologiesSimalungun Sumatera Utara, IndonesiaExporter to the US, Manufacturer0000api.fda.gov
PT K-Tech IndustriesSimalungun Sumatera Utara, IndonesiaExporter to the US, Manufacturer0000api.fda.gov
PT Newpoint TechnologySimalungun Sumatera Utara, IndonesiaExporter to the US, Manufacturer0000api.fda.gov
PT Ywanjan TechnologyPelalawan Regency Riau, IndonesiaExporter to the US, Manufacturer0000api.fda.gov
PT. Medisafe TechnologiesKab. Deli Serdang Sumatera Utara, IndonesiaManufacturer0000api.fda.gov
PT. Sintong Unigolden GloveKISARAN Sumatera Utara, IndonesiaContract manufacturer0000api.fda.gov
Pt.shamrock Manufacturing Corp.MEDAN Sumatera Utara, IndonesiaManufacturer0000api.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.