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Data / Medical devices / Polymer Patient Examination Glove / Indonesia

FDA-registered makers of Polymer Patient Examination Glove in Indonesia: 12 establishments

12 establishments in Indonesia are registered with the FDA to make Polymer Patient Examination Glove (product code LZA). 12 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
Polymer Patient Examination Glove
Product code
LZA
Country
Indonesia

Makers of Polymer Patient Examination Glove in Indonesia

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
PT. Medisafe TechnologiesKab. Deli Serdang Sumatera Utara, IndonesiaContract manufacturer, Manufacturer14August 28, 2023000api.fda.gov
Arista Latindo Industrial, Ltd. P.T.Jakarta Barat, IndonesiaManufacturer4September 23, 2003000api.fda.gov
PT Newpoint TechnologySimalungun Sumatera Utara, IndonesiaExporter to the US, Manufacturer4August 27, 2025000api.fda.gov
PT Basic International SumateraSimalungun Regency Sumatera Utara, IndonesiaContract manufacturer, Manufacturer3August 27, 2025000api.fda.gov
PT Greatview TechnologiesSimalungun Sumatera Utara, IndonesiaManufacturer3February 18, 2025000api.fda.gov
PT K-Tech IndustriesSimalungun Sumatera Utara, IndonesiaExporter to the US, Manufacturer3February 18, 2025000api.fda.gov
Pt.shamrock Manufacturing Corp.MEDAN Sumatera Utara, IndonesiaManufacturer3May 23, 2022000api.fda.gov
P.T. Maja Agung LatexindoSUNGGAL DELI SERDANG Sumatera Utara, IndonesiaManufacturer2May 18, 2022000api.fda.gov
PT Healthguard TechnologiesSimalungun Sumatera Utara, IndonesiaContract manufacturer, Exporter to the US, Manufacturer2February 18, 2025000api.fda.gov
PT Ywanjan TechnologyPelalawan Regency Riau, IndonesiaExporter to the US, Manufacturer2February 18, 2025000api.fda.gov
PT. Sintong Unigolden GloveKISARAN Sumatera Utara, IndonesiaContract manufacturer, Manufacturer1October 26, 2022000api.fda.gov
PT. Universal GlovesMEDAN Sumatera Utara, IndonesiaManufacturer1January 15, 2022000api.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.