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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K904361
Device Name KLEARTEX LATEX SURGEONS GLOVES
Applicant
Kleartex Sdn Bhd
Transcorp.
40 Dogwood Dr.
Chester,  NJ  07930
Applicant Contact KENNEDY PH.D.
Correspondent
Kleartex Sdn Bhd
Transcorp.
40 Dogwood Dr.
Chester,  NJ  07930
Correspondent Contact KENNEDY PH.D.
Regulation Number878.4460
Classification Product Code
KGO  
Date Received09/24/1990
Decision Date 12/07/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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