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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K172942
Device Name Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein
Applicant
Beta Healthcare Products Pvt., Ltd.
Plot No 21b, Cochin Special Economic Zone
Kakkanad
Kochi,  IN 682037
Applicant Contact Boney Moolayil
Correspondent
M/S Liberty Management Group, Ltd.
75 Executive Dr., Suite 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number878.4460
Classification Product Code
KGO  
Date Received09/26/2017
Decision Date 01/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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