FDA 510(k) Application Details - K024016

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K024016
Device Name Vinyl Patient Examination Glove
Applicant TOP GLOVE (ZHANGJIAGANG) CO. LTD.
3, ZHANGJIAGANG XI TANG ROAD
XI ZHANG TOWN 215614 CN
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Contact LIM WEE CHAI
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 12/04/2002
Decision Date 02/03/2003
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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