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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 K915127
Device Name MED.EXAM.GLOVES POWDERED ANATOMICALLY CORRECT
Applicant
Hedd Roz Canada, Inc.
P.O.Box 40027
Highfield P.O.Calgary
Alberta,  CA T2G5G5
Applicant Contact TREVOR REIDY
Correspondent
Hedd Roz Canada, Inc.
P.O.Box 40027
Highfield P.O.Calgary
Alberta,  CA T2G5G5
Correspondent Contact TREVOR REIDY
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/13/1991
Decision Date 02/11/1992
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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