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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 K111464
Device Name PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES
Applicant
Dipped Products (Thailand), Ltd.
82/2 Moo 9, Tumbon Rattapum
Amphur Khun Nieng
Songkla,  TH 90220
Applicant Contact L.G.S. GUNAWARDANA
Correspondent
Dipped Products (Thailand), Ltd.
82/2 Moo 9, Tumbon Rattapum
Amphur Khun Nieng
Songkla,  TH 90220
Correspondent Contact L.G.S. GUNAWARDANA
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/26/2011
Decision Date 04/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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