NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)


Device Classification Name

polymer patient examination glove

510(k) Number K111248
Device Name NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)
Applicant
YTY INDUSTRY (MANJUNG) SDN. BHD.
198 avenue de la d’emerald
sparks, 
NV 
89434 -9550

Applicant Contact janna tucker
Correspondent
YTY INDUSTRY (MANJUNG) SDN. BHD.
198 avenue de la d’emerald
sparks, 
NV 
89434 -9550

Correspodent Contact janna tucker
Regulation Number 880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received 05/03/2011
Decision Date 12/01/2011
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