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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 K992128
Device Name DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS
Applicant
DASH MEDICAL GLOVES SDN BHD
10180 SOUTH 54TH ST.
FRANKLIN,  WI  53132
Applicant Contact ROBERT J SULLIVAN JR
Correspondent
DASH MEDICAL GLOVES SDN BHD
10180 SOUTH 54TH ST.
FRANKLIN,  WI  53132
Correspondent Contact ROBERT J SULLIVAN JR
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/23/1999
Decision Date 09/14/1999
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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