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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 K994416
Device Name POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Applicant
FLEXITECH SDN. BHD.
LOT 5071, BATU 5 1/2, JALAN
MERU
KLANG, SELANGOR,  MY 41050
Applicant Contact Y. F HEW
Correspondent
FLEXITECH SDN. BHD.
LOT 5071, BATU 5 1/2, JALAN
MERU
KLANG, SELANGOR,  MY 41050
Correspondent Contact Y. F HEW
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/29/1999
Decision Date 02/03/2000
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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