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
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| PT. Medisafe Technologies | Kab. Deli Serdang Sumatera Utara, Indonesia | Contract manufacturer, Manufacturer | 14 | August 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Arista Latindo Industrial, Ltd. P.T. | Jakarta Barat, Indonesia | Manufacturer | 4 | September 23, 2003 | 0 | 0 | 0 | api.fda.gov |
| PT Newpoint Technology | Simalungun Sumatera Utara, Indonesia | Exporter to the US, Manufacturer | 4 | August 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| PT Basic International Sumatera | Simalungun Regency Sumatera Utara, Indonesia | Contract manufacturer, Manufacturer | 3 | August 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| PT Greatview Technologies | Simalungun Sumatera Utara, Indonesia | Manufacturer | 3 | February 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| PT K-Tech Industries | Simalungun Sumatera Utara, Indonesia | Exporter to the US, Manufacturer | 3 | February 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Pt.shamrock Manufacturing Corp. | MEDAN Sumatera Utara, Indonesia | Manufacturer | 3 | May 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| P.T. Maja Agung Latexindo | SUNGGAL DELI SERDANG Sumatera Utara, Indonesia | Manufacturer | 2 | May 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| PT Healthguard Technologies | Simalungun Sumatera Utara, Indonesia | Contract manufacturer, Exporter to the US, Manufacturer | 2 | February 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| PT Ywanjan Technology | Pelalawan Regency Riau, Indonesia | Exporter to the US, Manufacturer | 2 | February 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| PT. Sintong Unigolden Glove | KISARAN Sumatera Utara, Indonesia | Contract manufacturer, Manufacturer | 1 | October 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| PT. Universal Gloves | MEDAN Sumatera Utara, Indonesia | Manufacturer | 1 | January 15, 2022 | 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.