FDA 510(k) Application Details - K033496

Device Classification Name Latex Patient Examination Glove

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510(K) Number K033496
Device Name Latex Patient Examination Glove
Applicant INDUSTRIAL CLOTHINGS, LTD.
255 DUNCANMILL ROAD
SUITE 904
TORONTO M3B 3H9 CA
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Contact ALBINA BIANCHI
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 11/05/2003
Decision Date 03/09/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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