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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K103670
Device Name NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)
Applicant
Innovative Gloves Co;, Ltd.
800 Moo 4,Saambin-Ban Klang
Rd Kuanlang
Hatyai, Songkhla,  TH 90110
Applicant Contact RAJEEV SOOD
Correspondent
Innovative Gloves Co;, Ltd.
800 Moo 4,Saambin-Ban Klang
Rd Kuanlang
Hatyai, Songkhla,  TH 90110
Correspondent Contact RAJEEV SOOD
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/16/2010
Decision Date 03/31/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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