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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 K905667
Device Name LANEX EXAM GLOVES
Applicant
Mokiem & Julian Industrial Corp.
2460 Mariondale Ave.
Los Angeles,  CA  90032
Applicant Contact BEN CHANG
Correspondent
Mokiem & Julian Industrial Corp.
2460 Mariondale Ave.
Los Angeles,  CA  90032
Correspondent Contact BEN CHANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/18/1990
Decision Date 01/02/1991
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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