POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE


Device Classification Name

latex patient examination glove

510(k) Number K022016
Device Name POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE
Original Applicant
TOP GLOVE MEDICAL (THAILAND) CO., LTD.
no 58 moo 7 karnchanawanich rd
prik, sadao
songkhla, 

TH

90120

Original Contact audie seow
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 06/20/2002
Decision Date 10/15/2002
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