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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 K891630
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Inter-Continental Industries Sdn Bhd
23a Wisma Rank Jalan Barat Off
Jalan Imbi, P.O. Box 11846
50760 Kuala Lumpur,  MY
Applicant Contact PUN, ONG
Correspondent
Inter-Continental Industries Sdn Bhd
23a Wisma Rank Jalan Barat Off
Jalan Imbi, P.O. Box 11846
50760 Kuala Lumpur,  MY
Correspondent Contact PUN, ONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/17/1989
Decision Date 05/11/1989
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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