NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS)


Device Classification Name

latex patient examination glove

510(k) Number K072406
Device Name NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS)
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
LYY  
Date Received 08/27/2007
Decision Date 03/21/2008
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