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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 K974223
Device Name NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES
Applicant
DERLIN COMPANY LTD.
1601 HENRY PLACE
WAUKEGAN,  IL  60085
Applicant Contact JOHN BUCHER
Correspondent
DERLIN COMPANY LTD.
1601 HENRY PLACE
WAUKEGAN,  IL  60085
Correspondent Contact JOHN BUCHER
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/12/1997
Decision Date 12/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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