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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K011198
Device Name SENICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE, SENSICARE ADVANTIX POWDER FREE POLYURETHANE DENTAL
Applicant
Maxxim Medical, Inc.
10300 49th St. N.
Clearwater,  FL  33762
Applicant Contact JAMAL S ALNASER
Correspondent
N.V. Kema
P.O. Box 9035
6800 Et Arnhem
Arnhem,  NL
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/19/2001
Decision Date 05/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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