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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 K900212
Device Name SURETEX LATEX EXAMINATION GLOVES
Applicant
Gulf Medical Technologies, Inc.
P.O. Box 1418
Cidra
Puerto Rico, Oo639, 
Applicant Contact VICTOR U MEDINA
Correspondent
Gulf Medical Technologies, Inc.
P.O. Box 1418
Cidra
Puerto Rico, Oo639, 
Correspondent Contact VICTOR U MEDINA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/17/1990
Decision Date 01/23/1990
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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