POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM


Device Classification Name

latex patient examination glove

510(k) Number K112612
Device Name POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM
Applicant
TOP CALIBRE SDN BHD
1-1,2 jalan setia prima u13/s
setia alam, seksyen u13
shah alam, selangor, 

MY

40170

Applicant Contact tracy ngui
Correspondent
TOP CALIBRE SDN BHD
1-1,2 jalan setia prima u13/s
setia alam, seksyen u13
shah alam, selangor, 

MY

40170

Correspodent Contact tracy ngui
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 09/07/2011
Decision Date 01/18/2012
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