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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 K892163
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Canada Packers, Inc.
3080 Yonge St.
Toronto, Ontario,  CA M4N 3N1
Applicant Contact ANDREW WU
Correspondent
Canada Packers, Inc.
3080 Yonge St.
Toronto, Ontario,  CA M4N 3N1
Correspondent Contact ANDREW WU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/07/1989
Decision Date 10/31/1989
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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