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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 K012067
Device Name CLINCARE LATEX SURGEON'S GLOVE
Applicant
Ttk Healthcare , Ltd.
1219 Little Creek Rd.
Durham,  NC  27713
Applicant Contact ELI J CARTER
Correspondent
Ttk Healthcare , Ltd.
1219 Little Creek Rd.
Durham,  NC  27713
Correspondent Contact ELI J CARTER
Regulation Number878.4460
Classification Product Code
KGO  
Date Received07/02/2001
Decision Date 09/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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