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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K061192
Device Name BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
Applicant
Ethicon Endo-Surgery, LLC
4545 Creek Rd.
Cincinnati,  OH  45242
Applicant Contact ELIZABETH MILLER,MST
Correspondent
Ethicon Endo-Surgery, LLC
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact ELIZABETH MILLER,MST
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/28/2006
Decision Date 05/23/2006
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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