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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 K030386
Device Name POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE
Applicant
Shamrock Manufacturing Company
5445 Daniels St.
Chino,  CA  91710
Applicant Contact EMMY TJOENG
Correspondent
Shamrock Manufacturing Company
5445 Daniels St.
Chino,  CA  91710
Correspondent Contact EMMY TJOENG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/05/2003
Decision Date 03/28/2003
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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