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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 K893154
Device Name LATEX EXAMINATION GLOVES
Applicant
Magna Intl., Inc.
Orangegate Plz., 6th Floor
5455 Garden Grove Blvd.
Westminster,  CA  92683
Applicant Contact GILBERT M NISHIMURA
Correspondent
Magna Intl., Inc.
Orangegate Plz., 6th Floor
5455 Garden Grove Blvd.
Westminster,  CA  92683
Correspondent Contact GILBERT M NISHIMURA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/14/1989
Decision Date 09/13/1989
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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