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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 K000953
Device Name DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
Applicant
SHANGHAI ANTARES INDUSTRIES, INC.
259 YUSHU RD.,
CANGQIAO TOWNSHIP
SONGJIANG SHANGHAI,  CN
Applicant Contact JOHN LAI
Correspondent
SHANGHAI ANTARES INDUSTRIES, INC.
259 YUSHU RD.,
CANGQIAO TOWNSHIP
SONGJIANG SHANGHAI,  CN
Correspondent Contact JOHN LAI
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/24/2000
Decision Date 04/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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