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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 K891723
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Khoo Chemical Industrial Sdn Bhd
47-12, Jalan Dato Haji Hassan
Muar, Johore,  MY 84000
Applicant Contact SIM CHUAN
Correspondent
Khoo Chemical Industrial Sdn Bhd
47-12, Jalan Dato Haji Hassan
Muar, Johore,  MY 84000
Correspondent Contact SIM CHUAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/21/1989
Decision Date 09/13/1989
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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