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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 K955918
Device Name SINOCHEM NINGBO LATEX EXAMINATION GLOVE, POWDER FREE
Applicant
Sinochem Ningbo Imp & Exp Corp.
19001 S. Richfield # 185
Green Valley,  AZ  85614
Applicant Contact JANNA P TUCKER
Correspondent
Sinochem Ningbo Imp & Exp Corp.
19001 S. Richfield # 185
Green Valley,  AZ  85614
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/20/1995
Decision Date 06/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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