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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K891833
Device Name GLOUCH(TM) PATIENT EXAMINATION GLOVES
Applicant
Vadax, Inc.
115 Perimeter Center Pl.
Atlanta,  GA  30346
Applicant Contact LINDSEY WALTERS
Correspondent
Vadax, Inc.
115 Perimeter Center Pl.
Atlanta,  GA  30346
Correspondent Contact LINDSEY WALTERS
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/27/1989
Decision Date 08/22/1989
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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