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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 K974114
Device Name DASH, VITAL GARD
Applicant
DASH MEDICAL GLOVES SDN BHD
10180 SOUTH 54TH ST.
FRANKLIN,  WI  53132
Applicant Contact ROBERT J SULLIVAN
Correspondent
DASH MEDICAL GLOVES SDN BHD
10180 SOUTH 54TH ST.
FRANKLIN,  WI  53132
Correspondent Contact ROBERT J SULLIVAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received10/31/1997
Decision Date 12/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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