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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 K974710
Device Name NITRILE EXAM GLOVE, POWDER-FREE/WHITE AND BLUE
Applicant
Sinochem Ningbo Latex Gloves Factory
19001 S. Richfield # 185
Green Valley,  AZ  85614
Applicant Contact JANNA P TUCKER
Correspondent
Sinochem Ningbo Latex Gloves Factory
19001 S. Richfield # 185
Green Valley,  AZ  85614
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/17/1997
Decision Date 02/25/1998
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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