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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
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