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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K021041
Device Name WA RUBBERMATE LATEX POWDER-FREE EXAM GLOVES
Applicant
W.A. Rubbermate Co., Ltd.
22411 60th St.
Bristol,  WI  53104
Applicant Contact LARA N SIMMONS
Correspondent
W.A. Rubbermate Co., Ltd.
22411 60th St.
Bristol,  WI  53104
Correspondent Contact LARA N SIMMONS
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/01/2002
Decision Date 07/30/2002
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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