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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 K002718
Device Name ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB
Applicant
TILLOTSON HEALTHCARE CORP.
360 ROUTE 101
BEDFORD,  NH  03110 -5030
Applicant Contact F.W. PERRELLA
Correspondent
TILLOTSON HEALTHCARE CORP.
360 ROUTE 101
BEDFORD,  NH  03110 -5030
Correspondent Contact F.W. PERRELLA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/31/2000
Decision Date 05/01/2001
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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