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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 K981488
Device Name GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION
Applicant
Oak Carolina, Inc.
100 Roe Rd.
Travelers Rest,  SC  29690
Applicant Contact DARRELL W ALFORD
Correspondent
Oak Carolina, Inc.
100 Roe Rd.
Travelers Rest,  SC  29690
Correspondent Contact DARRELL W ALFORD
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/27/1998
Decision Date 07/07/1998
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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