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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 K954967
Device Name GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES
Applicant
Guthrie Medicare Products (Melaka) Sdn Bhd
7400 N. Oracle
Suite 330
Tucson,  AZ  85704
Applicant Contact KATHY SALFINGERE
Correspondent
Guthrie Medicare Products (Melaka) Sdn Bhd
7400 N. Oracle
Suite 330
Tucson,  AZ  85704
Correspondent Contact KATHY SALFINGERE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/30/1995
Decision Date 04/15/1996
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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