STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES


Device Classification Name

latex patient examination glove

510(k) Number K021521
Device Name STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES
Original Applicant
SMART GLOVE CORP. SDN BHD
lot 6487 batu 5 3/4
jalan kapar
klang selangor, 

MY

42100

Original Contact ng yew soon
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 05/10/2002
Decision Date 07/02/2002
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