POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)


codes

Device Classification Name

latex patient examination glove

510(k) Number K002568
Device Name POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Original Applicant
SMART GLOVE CORP. SDN BHD
lot 6487 batu 5 3/4
jalan kapar
klang selangor, 

MY

42100

Original Contact foo k pu
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 08/18/2000
Decision Date 10/03/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No