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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K052568
Device Name ESTEEM STRETCHY VINYL GLOVE WITH COATING
Applicant
Cardinalhealth
1500 Waukegan Rd.
Bldg. Wm
Mcgaw Park,  IL  60085
Applicant Contact AMY HOYD
Correspondent
Intertek Testing Services
70 Codman Hill Rd.
Boxborough,  MA  01719
Correspondent Contact NEIL E DEVINE
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/19/2005
Decision Date 11/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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