FDA 510(k) Application Details - K110247

Device Classification Name Polymer Patient Examination Glove

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510(K) Number K110247
Device Name Polymer Patient Examination Glove
Applicant JIANGSU DONGLING PLASTIC & RUBBER CO., LTD
ROOM 1606 BUILDING 1,JIAN XIAN
YUAN NO.209 BEI SI HUAN ZHONG
BEIJING 100083 CN
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Contact CHU XIAOAN
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Regulation Number 880.6250

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Classification Product Code LZA
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Date Received 01/28/2011
Decision Date 06/10/2011
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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