TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)


Device Classification Name

latex patient examination glove

510(k) Number K021855
Device Name TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)
Original Applicant
TOP GLOVE SDN. BHD.
lot 4968, bt 6, jalan teratai
off jalan meru
klang, selangor, 

MY

41050

Original Contact lim wee chai
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 06/06/2002
Decision Date 08/05/2002
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