POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)


Device Classification Name

polymer patient examination glove

510(k) Number K122131
Device Name POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)
Applicant
MATANG MFG. SDN. BHD.
lot 10, kawasan perindustrian
serkam, mukim serkam
merlimau, melaka, 

MY

77300

Applicant Contact leslie leong
Correspondent
MATANG MFG. SDN. BHD.
lot 10, kawasan perindustrian
serkam, mukim serkam
merlimau, melaka, 

MY

77300

Correspodent Contact leslie leong
Regulation Number 880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received 07/18/2012
Decision Date 10/17/2012
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