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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 K023702
Device Name POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE
Applicant
NINGBO TIANSHUN RUBBER PRODUCTS CO., LTD.
198 AVENUE DE LA D'EMERALD
SPARKS,  NV  89434 -9550
Applicant Contact JANNA P TUCKER
Correspondent
NINGBO TIANSHUN RUBBER PRODUCTS CO., LTD.
198 AVENUE DE LA D'EMERALD
SPARKS,  NV  89434 -9550
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/01/2002
Decision Date 12/18/2002
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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