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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 K981942
Device Name LATEX POWDER FREE EXAMINATION GLOVES
Applicant
Maika Rubber Products Sdn Bhd
1133 Fairlawn Ave.
Libertyville,  IL  60048
Applicant Contact RAVI ANBIL
Correspondent
Maika Rubber Products Sdn Bhd
1133 Fairlawn Ave.
Libertyville,  IL  60048
Correspondent Contact RAVI ANBIL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/02/1998
Decision Date 12/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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