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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 K892961
Device Name PATIENT EXAMINATION GLOVES
Applicant
Viratect, Inc.
75 W. Baseline
Suite 26
Gilbert,  AZ  85234
Applicant Contact LINNERSON, MD
Correspondent
Viratect, Inc.
75 W. Baseline
Suite 26
Gilbert,  AZ  85234
Correspondent Contact LINNERSON, MD
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/12/1989
Decision Date 06/14/1989
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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