FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)


Device Classification Name

latex patient examination glove

510(k) Number K121591
Device Name FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)
Applicant
TEKMEDIC (M) SDN BHD
plot 4, tanjung kling
industrial area, tanjung bruas
jetty, tanjung kling, malacca, 

MY

76400

Applicant Contact patrick leong
Correspondent
TEKMEDIC (M) SDN BHD
plot 4, tanjung kling
industrial area, tanjung bruas
jetty, tanjung kling, malacca, 

MY

76400

Correspodent Contact patrick leong
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 05/31/2012
Decision Date 10/11/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized