NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES


Device Classification Name

polymer patient examination glove

510(k) Number K072400
Device Name NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES
Applicant
SGMP CO., LTD.
198 avenue de la d’emerald
sparks, 
NV 
89434

Applicant Contact janna p tucker
Correspondent
SGMP CO., LTD.
198 avenue de la d’emerald
sparks, 
NV 
89434

Correspodent Contact janna p tucker
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 08/27/2007
Decision Date 03/27/2008
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