MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE


Device Classification Name

latex patient examination glove

510(k) Number K072614
Device Name MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE
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
LYY  
Date Received 09/17/2007
Decision Date 04/15/2008
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