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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 K012860
Device Name POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING CLAIM (<50UG/G)
Applicant
SGMP CO., LTD.
198 AVENUE DE LA D'EMERALD
SPARKS,  NV  89434
Applicant Contact JANNA P TUCKER
Correspondent
SGMP CO., LTD.
198 AVENUE DE LA D'EMERALD
SPARKS,  NV  89434
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/24/2001
Decision Date 09/21/2001
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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