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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 K970222
Device Name LOW PROTEIN LATEX EXAMINATION GLOVES
Applicant
KOSSAN LATEX INDUSTRIES (M) SDN. BHD.
LOT 16632, 5-1/4 MILES,
JALAN MERU
KELANG, SELANGOR,  MY 41050
Applicant Contact LIM KUANG SIA
Correspondent
KOSSAN LATEX INDUSTRIES (M) SDN. BHD.
LOT 16632, 5-1/4 MILES,
JALAN MERU
KELANG, SELANGOR,  MY 41050
Correspondent Contact LIM KUANG SIA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/21/1997
Decision Date 06/24/1997
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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