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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 K934316
Device Name GLOVE SEAL, POWDER FREE LATEX EXAMINATION GLOVES
Applicant
Contract Latex Dippers Sdn Bhd
50480 Kuala Lumpur,
Malaysia,  ML
Applicant Contact LIEW SE YEOH
Correspondent
Contract Latex Dippers Sdn Bhd
50480 Kuala Lumpur,
Malaysia,  ML
Correspondent Contact LIEW SE YEOH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/01/1993
Decision Date 03/11/1994
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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