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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 K012786
Device Name POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)
Applicant
SHAMROCK MANUFACTURING COMPANY
889 S. AZUSA AVE.
CITY OF INDUSTRY,  CA  91748
Applicant Contact EMMY TJOENG
Correspondent
SHAMROCK MANUFACTURING COMPANY
889 S. AZUSA AVE.
CITY OF INDUSTRY,  CA  91748
Correspondent Contact EMMY TJOENG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/20/2001
Decision Date 10/01/2001
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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