POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION GLOVES


Device Classification Name

latex patient examination glove

510(k) Number K023866
Device Name POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION GLOVES
Original Applicant
KL-KEPONG RUBBER PRODUCTS SDN. BHD.
ladang pinji, bahagian sengat,
kampung kepayang,
ipoh, perak, darul ridzuan, 

MY

31300

Original Contact yim hoon pung
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 11/20/2002
Decision Date 01/24/2003
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