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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 K893594
Device Name LATEX EXAMINATION GLOVES
Applicant
Glovetex Industries
Lot 11, Lengkungan Hishammudd-
In, Kaw 20, Selat Klang Utara
42000 Pelabuhan Klang,Sel,  MY
Applicant Contact JAMIL HARON
Correspondent
Glovetex Industries
Lot 11, Lengkungan Hishammudd-
In, Kaw 20, Selat Klang Utara
42000 Pelabuhan Klang,Sel,  MY
Correspondent Contact JAMIL HARON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/09/1989
Decision Date 07/14/1989
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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