LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN


Device Classification Name

latex patient examination glove

510(k) Number K991043
Device Name LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN
Applicant
GLOVCO (M) SDN. BHD.
lot 760,(block a),jalan haji
sirat,off jalan meru
klang, selangor d.e., 

MY

42100

Applicant Contact tan peng hock
Correspondent
GLOVCO (M) SDN. BHD.
lot 760,(block a),jalan haji
sirat,off jalan meru
klang, selangor d.e., 

MY

42100

Correspodent Contact tan peng hock
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 03/29/1999
Decision Date 05/04/1999
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