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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 K020943
Device Name STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREE
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 Received03/25/2002
Decision Date 06/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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