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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 K941900
Device Name POWDERED LATEX EXAM GLOVES
Applicant
Tg Medical Sdn. Bhd.
24, Jalan Raja Mokhtar Dua
Kapar, Selangor D.E.,  MY 42200
Applicant Contact LIM WEE CHAI
Correspondent
Tg Medical Sdn. Bhd.
24, Jalan Raja Mokhtar Dua
Kapar, Selangor D.E.,  MY 42200
Correspondent Contact LIM WEE CHAI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/19/1994
Decision Date 06/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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