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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 K923589
Device Name STERILE HYPOALLERGENIC POWDER-FREE LATEX SURG. GLV
Applicant
Tomarc (M) Sdn Bhd
5, Lorong Helang Hindik
Kepong Baru Industrial Estate
Kuala Lumpar,  MY 52100
Applicant Contact CHUCK JARRELL
Correspondent
Tomarc (M) Sdn Bhd
5, Lorong Helang Hindik
Kepong Baru Industrial Estate
Kuala Lumpar,  MY 52100
Correspondent Contact CHUCK JARRELL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/20/1992
Decision Date 07/23/1993
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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