MULTIPLE, BLUE POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT FLAVOR


Device Classification Name

polymer patient examination glove

510(k) Number K022818
Device Name MULTIPLE, BLUE POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
Original Applicant
SMART GLOVE CORP. SDN BHD
lot 6487 batu 5 3/4
jalan kapar
klang selangor, 

MY

42100

Original Contact foo khon pu
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 08/26/2002
Decision Date 09/17/2002
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