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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 K895438
Device Name S.M.P.U. LATEX EXAMINATION GLOVES
Applicant
P.T. Surya Milani Plastic Utama
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Applicant Contact ALAN P SCHWARTZ
Correspondent
P.T. Surya Milani Plastic Utama
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Correspondent Contact ALAN P SCHWARTZ
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/05/1989
Decision Date 10/31/1989
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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