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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K992219
Device Name POWDERED LATEX STERILE SURGICAL 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 Number878.4460
Classification Product Code
KGO  
Date Received07/01/1999
Decision Date 07/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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