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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 K896428
Device Name SEMPERMED LATEX EXAMINATION GLOVES
Applicant
Semperit Industrial Products
103 Spring Valley Rd.
Montvale,  NJ  07645
Applicant Contact MANFRED F REICHEL
Correspondent
Semperit Industrial Products
103 Spring Valley Rd.
Montvale,  NJ  07645
Correspondent Contact MANFRED F REICHEL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/08/1989
Decision Date 01/12/1990
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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