FDA 510(k) Application Details - K991749

Device Classification Name Latex Patient Examination Glove

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510(K) Number K991749
Device Name Latex Patient Examination Glove
Applicant LAGLOVE (M) SDN. BHD.
LOT 478, JALAN SIMPANG BALAK,
OFF BATU 13, JALAN CHERAS
KAJANG, SELANGOR, DARUL EHSAN 43000 MY
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Contact G. BASKARAN
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 05/24/1999
Decision Date 06/23/1999
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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