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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 K903107
Device Name PATIENT EXAM GLOVES (DUSTED W/USP STARCH POWDER)
Applicant
Ansell, Inc.
P.O. Box 18
Lat Krabang, Bangkok 10520
Thailand,  TH
Applicant Contact JOHN W MOUSHALL
Correspondent
Ansell, Inc.
P.O. Box 18
Lat Krabang, Bangkok 10520
Thailand,  TH
Correspondent Contact JOHN W MOUSHALL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/09/1990
Decision Date 08/29/1990
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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