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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 K110418
Device Name POWDER FREE NITRILE EXAMINATION GLOVES
Applicant
W.A. Rubbermate Co., Ltd.
Nongmaidaeng
A. Maung, Chonburi,  TH 20000
Applicant Contact TERENCE LIM SIN KOOI
Correspondent
W.A. Rubbermate Co., Ltd.
Nongmaidaeng
A. Maung, Chonburi,  TH 20000
Correspondent Contact TERENCE LIM SIN KOOI
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/14/2011
Decision Date 07/13/2011
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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