ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB


the company

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
Original Applicant
TILLOTSON HEALTHCARE CORP.
360 route 101
bedford, 
NH 
03110 -5030

Original Contact f.w. perrella
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 08/31/2000
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