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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 K930602
Device Name LATEX EXAMINATION GLOVES, POWDER FREE
Applicant
Tekmedic (M) Sdn Bhd
C/O Cal-American Medical Suppl
2651 Manhattan Beach Blvd.
Redondo Beach,  CA  90278
Applicant Contact WALLACE WONG
Correspondent
Tekmedic (M) Sdn Bhd
C/O Cal-American Medical Suppl
2651 Manhattan Beach Blvd.
Redondo Beach,  CA  90278
Correspondent Contact WALLACE WONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/02/1993
Decision Date 09/29/1993
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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