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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K973811
Device Name POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED)
Applicant
Absolute Quality Leadership, Inc.
726 W. Betteravia Rd.
Santa Maria,  CA  93455
Applicant Contact DONNA DI GANGI
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact TOM BOWMAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/07/1997
Decision Date 10/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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