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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 K903447
Device Name STERILE LATEX EXAMINATION GLOVES
Applicant
Sime Darby USA
330 Main St.
Chatham,  NJ  07928
Applicant Contact MARCIA L HALL
Correspondent
Sime Darby USA
330 Main St.
Chatham,  NJ  07928
Correspondent Contact MARCIA L HALL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/27/1990
Decision Date 09/19/1990
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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