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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 K101135
Device Name POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE,BLUE, PINK)
Applicant
Hongze Plastic Technology Co., Ltd.
1930 Brea Canyon Rd.
Diamond Bar,  CA  91765
Applicant Contact KATHY LIU
Correspondent
Hongze Plastic Technology Co., Ltd.
1930 Brea Canyon Rd.
Diamond Bar,  CA  91765
Correspondent Contact KATHY LIU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/22/2010
Decision Date 07/01/2010
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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