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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K993664
Device Name SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES
Applicant
Top Glove Sdn. Bhd.
Lot 4968, Bt 6, Jalan Teratai
Off Jalan Meru
Klang, Selangor,  MY 41050
Applicant Contact WEE-CHAI LIM
Correspondent
Top Glove Sdn. Bhd.
Lot 4968, Bt 6, Jalan Teratai
Off Jalan Meru
Klang, Selangor,  MY 41050
Correspondent Contact WEE-CHAI LIM
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/29/1999
Decision Date 01/11/2000
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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