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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K102094
Device Name POWDER FREE VINYL PATIENT EXAMINATION GLOVES
Applicant
GRAND WORK PLASTIC PRODUCTS CO., LTD.
DONGGAO INDUSTRIAL ZONE
ZANHUANG, HEBEI,  CN 050000
Applicant Contact KATHY LIU
Correspondent
GRAND WORK PLASTIC PRODUCTS CO., LTD.
DONGGAO INDUSTRIAL ZONE
ZANHUANG, HEBEI,  CN 050000
Correspondent Contact KATHY LIU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/05/2010
Decision Date 10/05/2010
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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