FDA 510(k) Application Details - K021668

Device Classification Name Polymer Patient Examination Glove

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510(K) Number K021668
Device Name Polymer Patient Examination Glove
Applicant INNOVATIVE GLOVES CO; LTD
500 M004, T. KUANLUNG, HATYAI,
SONGKHLA 90110 TH
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Contact RAJEEV KUMAR SOOD
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Regulation Number 880.6250

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Classification Product Code LZA
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Date Received 05/21/2002
Decision Date 08/12/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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