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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 K993452
Device Name GREEN POWDERED LATEX EXAMINATION GLOVES
Applicant
Top Glove Sdn. Bhd.
Lot 4968, Bt 6, Jalan Teratai
Off Jalan Meru
Klang, Selangor,  MY 41050
Applicant Contact T.S. PUON
Correspondent
Top Glove Sdn. Bhd.
Lot 4968, Bt 6, Jalan Teratai
Off Jalan Meru
Klang, Selangor,  MY 41050
Correspondent Contact T.S. PUON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/13/1999
Decision Date 12/20/1999
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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