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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 K993080
Device Name AMBIDERM LATEX EXAMINATION GLOVES (VIOLET, BLUE , GREEN, AND PINK) CONTAINING 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE
Applicant
Medtexx Partners, Inc.
P.O. Box 4341
Crofton,  MD  21114
Applicant Contact E. J SMITH
Correspondent
Medtexx Partners, Inc.
P.O. Box 4341
Crofton,  MD  21114
Correspondent Contact E. J SMITH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/14/1999
Decision Date 10/20/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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