FDA 510(k) Application Details - K032323

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K032323
Device Name Vinyl Patient Examination Glove
Applicant LONG FIRST (XIAMEN) PLASTICS CO., LTD.
2631 N. MAGNOLIA STREET
CHICAGO, IL 60614 US
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Contact CHIEN LIN
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 07/28/2003
Decision Date 10/07/2003
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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