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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 K891834
Device Name NIL PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Glatex Sdn Bhd
Lot 2756, Jalan Kempas Lama,
8 Mile, Jalan Skudai
Johor Baru, Johor,  MY 81300
Applicant Contact ANTHONY YEO
Correspondent
Glatex Sdn Bhd
Lot 2756, Jalan Kempas Lama,
8 Mile, Jalan Skudai
Johor Baru, Johor,  MY 81300
Correspondent Contact ANTHONY YEO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/27/1989
Decision Date 06/06/1989
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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