FDA 510(k) Application Details - K182528

Device Classification Name Polymer Patient Examination Glove

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510(K) Number K182528
Device Name Polymer Patient Examination Glove
Applicant Haining Medical Products Co., Ltd.
West of Dianchang Road, Luannan County
Tangshan 063500 CN
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Contact Zhiming Yao
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Regulation Number 880.6250

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Classification Product Code LZA
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Date Received 09/14/2018
Decision Date 11/15/2018
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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