FDA 510(k) Application Details - K171737

Device Classification Name Polymer Patient Examination Glove

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510(K) Number K171737
Device Name Polymer Patient Examination Glove
Applicant Ansell Healthcare Products LLC
111 Wood Avenue South, Suite 210
Iselin, NJ 08830 US
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Contact Robert Mahler
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Regulation Number 880.6250

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Classification Product Code LZA
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Date Received 06/12/2017
Decision Date 12/29/2017
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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