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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 K040681
Device Name SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
Applicant
GRAND WORK PLASTIC PRODUCTS CO., LTD.
DONGGAO INDUSTRIAL ZONE ZANHUANG
ZANHUANG COUNTY,  CN 050000
Applicant Contact JAMES CHU
Correspondent
GRAND WORK PLASTIC PRODUCTS CO., LTD.
590 W. CENTRAL AVE., #D
BREA,  CA  92821
Correspondent Contact JAMES CHU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/16/2004
Decision Date 06/03/2004
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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