FDA 510(k) Application Details - K021465

Device Classification Name Latex Patient Examination Glove

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510(K) Number K021465
Device Name Latex Patient Examination Glove
Applicant INDUSTRIAL CLOTHINGS, LTD.
481A, PRINCE OF WALES AVE.
COLOMBO 14 LK
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Contact UMAIR AHMED
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 05/07/2002
Decision Date 05/22/2002
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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