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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 K051662
Device Name VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR)
Applicant
Grand Work Plastic Products Co., Ltd.
Donggao Industrial Zone Zanhuang
Zanhuang County,  CN 050000
Applicant Contact MICKY LIN
Correspondent
Grand Work Plastic Products Co., Ltd.
3973 Schafer Ave.
Chino,  CA  91710
Correspondent Contact MICKY LIN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/22/2005
Decision Date 07/22/2005
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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