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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 K904324
Device Name LATEX EXAMINATION GLOVE
Applicant
Gallimore Ent., Inc.
19 Railside Rd.
Toronto Ont M3a 1b2,  CA
Applicant Contact WAYNE DRISCOLL
Correspondent
Gallimore Ent., Inc.
19 Railside Rd.
Toronto Ont M3a 1b2,  CA
Correspondent Contact WAYNE DRISCOLL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/14/1990
Decision Date 10/03/1990
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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