Medismart ( Latex Surgeon¿s Gloves Powdered ) And Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer Coated With Protein

Surgeon's Gloves

ST.MARYS RUBBERS PVT. LTD.

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.

Pre-market Notification Details

Device IDK151114
510k NumberK151114
Device Name:Medismart ( Latex Surgeon¿s Gloves Powdered ) And Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer Coated With Protein
ClassificationSurgeon's Gloves
Applicant ST.MARYS RUBBERS PVT. LTD. Koovappally P.O.Kanjirappally Kottayam District, Kerala,  IN 686518
ContactSrinivasan. S
CorrespondentManoj Zacharias
M/s Liberty Management Group Ltd 2871 Coastal Dr. Aurora,  IL  60503
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-27
Decision Date2015-12-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B031AHS91 K151114 000
60368001101273 K151114 000
60368001101280 K151114 000
60368001101297 K151114 000
00368001101318 K151114 000
80368001101321 K151114 000
60368001101334 K151114 000
B031AHS61 K151114 000
B031AHS651 K151114 000
B031AHS71 K151114 000
B031AHS751 K151114 000
B031AHS81 K151114 000
B031AHS851 K151114 000
60368001101266 K151114 000

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