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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K081089
Device Name KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM
Applicant
Kimberly-Clark Corp.
1400 Holcomb Bridge Rd.
Roswell,  GA  30076
Applicant Contact RICHARD V WOLFE
Correspondent
Kimberly-Clark Corp.
1400 Holcomb Bridge Rd.
Roswell,  GA  30076
Correspondent Contact RICHARD V WOLFE
Regulation Number880.6250
Classification Product Code
LZC  
Date Received04/16/2008
Decision Date 07/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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