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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 K982872
Device Name TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
TG MEDICAL SDN BHD
LOT 5091, JALAN TERATAI, BT 5,
OFF JLN MERU
KLANG, SELANGOR D.E.,  MY 41050
Applicant Contact W.C. LIM
Correspondent
TG MEDICAL SDN BHD
LOT 5091, JALAN TERATAI, BT 5,
OFF JLN MERU
KLANG, SELANGOR D.E.,  MY 41050
Correspondent Contact W.C. LIM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/14/1998
Decision Date 10/15/1998
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
Recalls CDRH Recalls
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