The following data is part of a premarket notification filed by St.marys Rubbers Pvt. Ltd. with the FDA for Medismart ( Latex Surgeon¿s Gloves Powdered ) And Medismart + (latex Surgeon¿s Gloves Powder Free, Polymer Coated With Protein.
| Device ID | K151114 |
| 510k Number | K151114 |
| Device Name: | Medismart ( Latex Surgeon¿s Gloves Powdered ) And Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer Coated With Protein |
| Classification | Surgeon's Gloves |
| Applicant | ST.MARYS RUBBERS PVT. LTD. Koovappally P.O.Kanjirappally Kottayam District, Kerala, IN 686518 |
| Contact | Srinivasan. S |
| Correspondent | Manoj Zacharias M/s Liberty Management Group Ltd 2871 Coastal Dr. Aurora, IL 60503 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-27 |
| Decision Date | 2015-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B031AHS91 | K151114 | 000 |
| B031AHS851 | K151114 | 000 |
| B031AHS81 | K151114 | 000 |
| B031AHS751 | K151114 | 000 |
| B031AHS71 | K151114 | 000 |
| B031AHS651 | K151114 | 000 |
| B031AHS61 | K151114 | 000 |