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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 K891434
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Sime Darby USA
320 W. Blvd.
Rapid City,  SD  57701
Applicant Contact FRED C WHITING
Correspondent
Sime Darby USA
320 W. Blvd.
Rapid City,  SD  57701
Correspondent Contact FRED C WHITING
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/15/1989
Decision Date 03/24/1989
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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