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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K092498
Device Name LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR)
Applicant
LAGLOVE (M) SDN. BHD.
LOT 478, JALAN SIMPANG BALAK,
OFF BATU 13, JALAN CHERAS
KAJANG, SELANGOR, DARUL EHSAN,  MY 43000
Applicant Contact G. BASKARAN
Correspondent
LAGLOVE (M) SDN. BHD.
LOT 478, JALAN SIMPANG BALAK,
OFF BATU 13, JALAN CHERAS
KAJANG, SELANGOR, DARUL EHSAN,  MY 43000
Correspondent Contact G. BASKARAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/14/2009
Decision Date 11/20/2009
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
Predetermined Change
Control Plan Authorized		 No
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