FDA 510(k) Application Details - K014280

Device Classification Name Latex Patient Examination Glove

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510(K) Number K014280
Device Name Latex Patient Examination Glove
Applicant BRIGHTWAY GLOVES PVT. LTD.
PIONEER MANIKANDAN BUILDINGS
VADASERY, NAGAR COIL
TAMIL NADU 629001 IN
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Contact N. PARAMASIVAN
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 12/27/2001
Decision Date 03/20/2002
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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