POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE)


Device Classification Name

polymer patient examination glove

510(k) Number K050122
Device Name POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE)
Applicant
SMART GLOVE CORP. SDN BHD
lot 6487 batu 5 3/4
jalan kapar
klang selangor, 

MY

42100

Applicant Contact foo khon pu
Correspondent
SMART GLOVE CORP. SDN BHD
lot 6487 batu 5 3/4
jalan kapar
klang selangor, 

MY

42100

Correspodent Contact foo khon pu
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 01/19/2005
Decision Date 04/18/2005
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