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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 K894450
Device Name LATEX PATIENT EXAMINATION GLOVES
Applicant
Kannex Gloves, Div. of Kanoi Plantations Private
Hongkong House, Second Floor
31, B. B. D. Bag(S)
Calcutta-700001, India,  IN
Applicant Contact KUMAR KANOI
Correspondent
Kannex Gloves, Div. of Kanoi Plantations Private
Hongkong House, Second Floor
31, B. B. D. Bag(S)
Calcutta-700001, India,  IN
Correspondent Contact KUMAR KANOI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/19/1989
Decision Date 02/13/1990
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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