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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name latex patient examination glove
510(k) Number K093193
Device Name LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET)
Applicant
LA GLOVE (M) SDN. BHD.
LOT 478 JALAN SIMPANG BALAK,
OFF BATU 13, JALAN CHERAS
KAJANG SELANGPR D.E.,  MY 43000
Applicant Contact G BASKARAN
Correspondent
LA GLOVE (M) SDN. BHD.
LOT 478 JALAN SIMPANG BALAK,
OFF BATU 13, JALAN CHERAS
KAJANG SELANGPR D.E.,  MY 43000
Correspondent Contact G BASKARAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/13/2009
Decision Date 06/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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