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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K992841
Device Name TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES
Applicant
Tg Medical Sdn. Bhd.
Lot 5091, Jalan Teratai, Bt 5,
Off Jln Meru
Klang, Selangor D.E.,  MY 41050
Applicant Contact WEE-CHAI LIM
Correspondent
Tg Medical Sdn. Bhd.
Lot 5091, Jalan Teratai, Bt 5,
Off Jln Meru
Klang, Selangor D.E.,  MY 41050
Correspondent Contact WEE-CHAI LIM
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/24/1999
Decision Date 10/29/1999
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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