FDA 510(k) Application Details - K072145

Device Classification Name Latex Patient Examination Glove

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510(K) Number K072145
Device Name Latex Patient Examination Glove
Applicant ZHANJIANG JIALI GLOVE PRODUCTS CO., LTD
SUITE 8D, NO. 19, LANE 999
ZHONGSHAN NO. 2 ROAD
SHANGHAI 200030 CN
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Contact Diana Hong
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 08/02/2007
Decision Date 02/26/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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