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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 K122363
Model BLUE: ALL SIZES (XS-XL)
Device Name NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Applicant
SIAM SEMPERMED CORP. LTD.
13900 49th street north
clearwater,  FL  33762
Contact william e harris
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/06/2012
Decision Date 09/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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