Data / Medical devices / India / Sanrea Healthcare Products Pvt Ltd
Sanrea Healthcare Products Pvt Ltd: FDA-registered device maker in Palakkad Kerala, India, 1 510(k) clearance
Sanrea Healthcare Products Pvt Ltd is registered with the FDA (registration 3013530281) in Palakkad Kerala, India. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 19, 2017. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3013530281
- Address
- Plot # P-56, Pearl Road Kinfra Integrated Industrial & Textile Park, Kanjikode, Palakkad Kerala, India, 678 621
- Owner or operator
- SANREA HEALTHCARE PRODUCTS PVT LTD (10053578)
- Roles
- Manufacturer
- First device listed
- December 19, 2016
- Registered through
- 2026
- Brand names listed
- Dynarex, GLOVTek, SanCare, Sterile Latex Examination Gloves Powderfree, Sterile Latex Surgical Gloves Powderfree, Sterile Nitrile Examination Gloves Powderfree
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 19, 2017 | K171093 | STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE | LZA | Substantially Equivalent | Sanrea Healthcare Products Pvt, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Latex Patient Examination Glove
- All makers of Surgeon'S Gloves
Updated July 19, 2017. 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.