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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 K910542
Device Name DIGIFLEX, LATEX PATIENT EXAMINATION GLOVES
Applicant
21st Century Group
15 Bardwell St., Suite 3
Boston,  MA  02130
Applicant Contact MICHAEL C CONROY
Correspondent
21st Century Group
15 Bardwell St., Suite 3
Boston,  MA  02130
Correspondent Contact MICHAEL C CONROY
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/05/1991
Decision Date 02/19/1991
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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