FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A


definition

Device Classification Name

latex patient examination glove

510(k) Number K002719
Device Name FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A
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 01/26/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No