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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 K892168
Device Name LATEX EXAM GLOVES (SURGICAL TYPE GLOVE)
Applicant
Hands-On Packaging , Ltd.
515 Dotzert Ct.
Unit #6
Waterloo, Ontario Canada,  CA N2L 6A7
Applicant Contact ERIC PENROSE
Correspondent
Hands-On Packaging , Ltd.
515 Dotzert Ct.
Unit #6
Waterloo, Ontario Canada,  CA N2L 6A7
Correspondent Contact ERIC PENROSE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/05/1989
Decision Date 07/14/1989
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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