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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 K891422
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
United Fortune International, Inc.
P.O. Box 2965
13225 Barton Cir.
Santa Fe Springs,  CA  90670
Applicant Contact THONY INDUSTRY
Correspondent
United Fortune International, Inc.
P.O. Box 2965
13225 Barton Cir.
Santa Fe Springs,  CA  90670
Correspondent Contact THONY INDUSTRY
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/14/1989
Decision Date 05/12/1989
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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