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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 K920174
Device Name EASY TOUCH LATEX EAM GLOVES
Applicant
Simpex, Inc.
801 Old York Rd.
Suite 318
Jenkintown,  PA  19046
Applicant Contact XI MEI
Correspondent
Simpex, Inc.
801 Old York Rd.
Suite 318
Jenkintown,  PA  19046
Correspondent Contact XI MEI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/14/1992
Decision Date 04/22/1992
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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