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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 K892073
Device Name TAGUM LATEX EXAMINATION GLOVES
Applicant
Tagum Rubber Industries, Ltd.
11, Galgalei Haplada
Industrial Zone
Herzlia B 46 733, Israel,  IL
Applicant Contact SHAUL VAGMAN
Correspondent
Tagum Rubber Industries, Ltd.
11, Galgalei Haplada
Industrial Zone
Herzlia B 46 733, Israel,  IL
Correspondent Contact SHAUL VAGMAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/03/1989
Decision Date 12/05/1989
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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