ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE


Device Classification Name

polymer patient examination glove

510(k) Number K110960
Device Name ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE
Applicant
KOON SENG SDN.BHD
5401 s. cottonwood ct.
greenwood village, 
CO 
80121

Applicant Contact kevin walls
Correspondent
KOON SENG SDN.BHD
5401 s. cottonwood ct.
greenwood village, 
CO 
80121

Correspodent Contact kevin walls
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 04/05/2011
Decision Date 07/14/2011
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