FDA 510(k) Application Details - K200072

Device Classification Name Polymer Patient Examination Glove

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510(K) Number K200072
Device Name Polymer Patient Examination Glove
Applicant Kimberly-Clark Corporation
1400 Holcomb Bridge Road
Roswell, GA 30076 US
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Contact Juan Marquez
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Regulation Number 880.6250

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Classification Product Code LZA
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Date Received 01/14/2020
Decision Date 04/10/2020
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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