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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 K900453
Device Name MODIFIED SINGLE USE LATEX EXAMINATION GLOVES
Applicant
Phoenix Medical Technology, Inc.
Hwy. 521 W., P.O. Box 346
Andrews,  SC  29510
Applicant Contact J. F SAUVE'
Correspondent
Phoenix Medical Technology, Inc.
Hwy. 521 W., P.O. Box 346
Andrews,  SC  29510
Correspondent Contact J. F SAUVE'
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/30/1990
Decision Date 02/13/1990
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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