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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K891160
Device Name MIC NON-STERILE LATEX GLOVES
Applicant
Asia Dynamics, Inc.
5875 N. Lincoln Ave., Suite
243
Chicago,  IL  60659
Applicant Contact JEONGLING LIU
Correspondent
Asia Dynamics, Inc.
5875 N. Lincoln Ave., Suite
243
Chicago,  IL  60659
Correspondent Contact JEONGLING LIU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/06/1989
Decision Date 10/13/1989
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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