FDA 510(k) Application Details - K142570

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K142570
Device Name Vinyl Patient Examination Glove
Applicant EVER LIGHT PLASTIC PRODUCTS CO., LTD.
DONGGAO INDUSTRIAL ZONE
SHIJIAZHUANG CITY 050000 CN
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Contact ZHANG LITAO
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 09/12/2014
Decision Date 12/18/2014
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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