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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 K891127
Device Name PATIENT EXAMINATION GLOVE (LATEX)
Applicant
Sppik Rubber Industries Sdn. Bhd.
P.O. Box 11288
50740 Kuala Lumpur
Malaysia,  MY
Applicant Contact MOHD NOR
Correspondent
Sppik Rubber Industries Sdn. Bhd.
P.O. Box 11288
50740 Kuala Lumpur
Malaysia,  MY
Correspondent Contact MOHD NOR
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/03/1989
Decision Date 05/04/1989
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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