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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 K933810
Device Name POWDER FREE LATEX EXAMINATION GLOVES
Applicant
Clydesdale Industries Sdn. Bhd.
Ayer Keroh Industrial Estate
Malacca,  MY 75450
Applicant Contact LIM ENG CHUAN
Correspondent
Clydesdale Industries Sdn. Bhd.
Ayer Keroh Industrial Estate
Malacca,  MY 75450
Correspondent Contact LIM ENG CHUAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/04/1993
Decision Date 03/09/1994
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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