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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 K891821
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Koon Seng Sdn Bhd
Plo. 89, Jalan Tembaga Dua
Pasir Gudang Industrial Estate
81707 Pasir Gudan, Johor,  MY
Applicant Contact LEE CHUAN
Correspondent
Koon Seng Sdn Bhd
Plo. 89, Jalan Tembaga Dua
Pasir Gudang Industrial Estate
81707 Pasir Gudan, Johor,  MY
Correspondent Contact LEE CHUAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/24/1989
Decision Date 05/31/1989
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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