POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR LESS)


Device Classification Name

latex patient examination glove

510(k) Number K022530
Device Name POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR LESS)
Original Applicant
HYCARE INTL. CO., LTD.
198 ave. de la d’emerald
sparks, 
NV 
89434 -9550

Original Contact janna p tucker
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 07/31/2002
Decision Date 08/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No