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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 K894616
Device Name LATEX EXAMINATION GLOVES
Applicant
World Wide EX Im, Inc.
4567 W. 80th St.
Minneapolis,  MN  55437
Applicant Contact MARK KAISER
Correspondent
World Wide EX Im, Inc.
4567 W. 80th St.
Minneapolis,  MN  55437
Correspondent Contact MARK KAISER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/20/1989
Decision Date 09/26/1989
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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