FDA 510(k) Application Details - K990882

Device Classification Name Polymer Patient Examination Glove

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510(K) Number K990882
Device Name Polymer Patient Examination Glove
Applicant LAGLOVE (M) SDN. BHD.
JALAN SIMPANG BALAK, OFF BATU
13, JALAN CHERAS, 43000 KAJANG
SELANGOR DARUL EHSAN MALA MG
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Contact G. BASKARAN
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Regulation Number 880.6250

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Classification Product Code LZA
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Date Received 03/16/1999
Decision Date 05/21/1999
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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