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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 K994354
Device Name POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
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 Received12/23/1999
Decision Date 01/31/2000
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
Predetermined Change
Control Plan Authorized		 No
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