Data / Medical devices / Polymer Patient Examination Glove / India
FDA-registered makers of Polymer Patient Examination Glove in India: 6 establishments
6 establishments in India are registered with the FDA to make Polymer Patient Examination Glove (product code LZA). 5 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
- India
Makers of Polymer Patient Examination Glove in India
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Amazing Rubber Products Pvt. Ltd | COCHIN Kerala, India | Exporter to the US, Manufacturer | 2 | May 28, 2022 | 0 | 0 | 0 | api.fda.gov |
| Latrile Gloves Private Limited | DINDIGUL Tamil Nadu, India | Manufacturer | 1 | May 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Primus Gloves Private Ltd. | Kakkanad, Cochin, Kerala, India | Manufacturer, Specification developer | 1 | April 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Sanrea Healthcare Products Pvt Ltd | Palakkad Kerala, India | Manufacturer | 1 | July 19, 2017 | 0 | 0 | 0 | api.fda.gov |
| Tegamen Safety Products Pvt. Ltd. | Alwar Rajasthan, India | Exporter to the US, Manufacturer | 1 | March 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| Koove Iot Pvt. Ltd | MIDNAPUR West Bengal, India | Contract 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.