Data / Medical devices / India / St.marys Rubbers Pvt Ltd
St.marys Rubbers Pvt Ltd: FDA-registered device maker in Kottayam Kerala, India, 1 510(k) clearance
St.marys Rubbers Pvt Ltd is registered with the FDA (registration 3012551999) in Kottayam Kerala, India. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 11, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012551999
- Address
- Xvii / 401 A, Thottamkavala, Koovappally P O, Kanjirappally, Kottayam Kerala, India, 686518
- Owner or operator
- ST.MARYS RUBBERS PVT LTD (10050794)
- Roles
- Manufacturer
- First device listed
- December 28, 2015
- Registered through
- 2026
- Brand names listed
- Amerisourcebergen, ICP Meds, Med pride, Mediagni PF, Medismart, Medismart +, Medismart Premium Plus, Mediten PLus and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| December 11, 2015 | K151114 | Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein | KGO | Substantially Equivalent | St. Marys Rubbers Pvt, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 11, 2015. 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.