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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 K990468
Device Name LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING
Applicant
Top Glove Sdn. Bhd.
41050 Klang,Selangor
Darul Ehsan,  MY
Applicant Contact LIM WEE CHAI
Correspondent
Top Glove Sdn. Bhd.
41050 Klang,Selangor
Darul Ehsan,  MY
Correspondent Contact LIM WEE CHAI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/16/1999
Decision Date 04/27/1999
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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