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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 K890440
Device Name LATEX DECONTAMINATION/PROCEDURE GLOVES (NON-STER)
Applicant
Tomarc (M) Sdn Bhd
5, Lorong Helang Hindik
Kepong Baru Industrial Estate
Kuala Lumpar,  MY 52100
Applicant Contact SS FOO
Correspondent
Tomarc (M) Sdn Bhd
5, Lorong Helang Hindik
Kepong Baru Industrial Estate
Kuala Lumpar,  MY 52100
Correspondent Contact SS FOO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/27/1989
Decision Date 05/12/1989
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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