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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 K102089
Device Name GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES
Applicant
Grand Work Plastic Products Co., Ltd.
Donggao Industrial Zone Zanhuang
Zanhuang County,  CN 050000
Applicant Contact KATHY LIU
Correspondent
Grand Work Plastic Products Co., Ltd.
3973 Schafer Ave.
Chino,  CA  91710
Correspondent Contact KATHY LIU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/05/2010
Decision Date 10/06/2010
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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