Data / Medical devices / Gown, Examination / India
FDA-registered makers of Gown, Examination in India: 9 establishments
9 establishments in India are registered with the FDA to make Gown, Examination (product code FME). 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
- Gown, Examination
- Product code
- FME
- Country
- India
Makers of Gown, Examination in India
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Am Nonwovens | Madurai Tamil Nadu, India | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amaryllis Healthcare Pvt. Ltd | Bangalore Karnataka, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C K Hygiene Pvt Ltd | Hyderabad Telangana, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harmony Plastics Private Ltd | Surat Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hindustan Apparel Industries | Hyderabad Telangana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harmony Plastics P. Ltd. | Udaipur Rajasthan, India | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Speedway | India Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theni Guru Krishna Textile Mills (P) Ltd. | Theni Tamil Nadu, 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.