FDA 510(k) Application Details - K932283

Device Classification Name Latex Patient Examination Glove

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510(K) Number K932283
Device Name Latex Patient Examination Glove
Applicant EAC RUBBER INDUSTRIES (M) SDN. BHD.
P.O. BOX 240
46720 PETALING JAYA
MALAYSIA MY
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Contact EWE HUM
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 05/07/1993
Decision Date 05/02/1994
Decision SE - Substantially Equivalent
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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