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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 K931633
Device Name POWDER-FREE LATEX PATIENT EXAMINATION GLOVES
Applicant
Tomarc (M) Sdn Bhd
5, Lorong Helang Hindik
Kepong Baru Industrial Estate
Kuala Lumpar,  MY 52100
Applicant Contact LAU
Correspondent
Tomarc (M) Sdn Bhd
5, Lorong Helang Hindik
Kepong Baru Industrial Estate
Kuala Lumpar,  MY 52100
Correspondent Contact LAU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/02/1993
Decision Date 10/25/1993
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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