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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 K012499
Device Name ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
Applicant
SHANGHAI ANTARES INDUSTRIES, INC.
259 YUSHU RD.,
CANGQIAO TOWNSHIP
SONGJIANG COUNTY, SHANGHAI,  CN 201600
Applicant Contact JOHN LAI
Correspondent
SHANGHAI ANTARES INDUSTRIES, INC.
259 YUSHU RD.,
CANGQIAO TOWNSHIP
SONGJIANG COUNTY, SHANGHAI,  CN 201600
Correspondent Contact JOHN LAI
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/03/2001
Decision Date 10/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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