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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K992018
Device Name LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)
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 Number878.4460
Classification Product Code
KGO  
Date Received06/16/1999
Decision Date 07/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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