NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735


Device Classification Name

polymer patient examination glove

510(k) Number K030207
Device Name NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735
Original Applicant
SHANGHAI MOTEX HEALTHCARE CO., LTD.
no.6318, fang huang rd, huaxin
qingpu, shanghai, 

CN

201708

Original Contact tony t.k. cheng
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 01/21/2003
Decision Date 05/02/2003
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