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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 K903142
Device Name AUKUFLEX(TM) RADIATION RESISTANT GLOVES
Applicant
Aukland Mfg., Inc.
111 Woodwinds Industrial Ct.
Cary,  NC  27511
Applicant Contact NORMAN A GRAY
Correspondent
Aukland Mfg., Inc.
111 Woodwinds Industrial Ct.
Cary,  NC  27511
Correspondent Contact NORMAN A GRAY
Regulation Number880.6250
Classification Product Code
LZC  
Date Received07/17/1990
Decision Date 10/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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