POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)


Device Classification Name

polymer patient examination glove

510(k) Number K030284
Device Name POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)
Original Applicant
PT. SMARTGLOVE INDONESIA
star jl.raya medan-lubuk pakam
km.19, tg.marowa b-tg.marowa
deli serdang,sumatera utara, 

ID

20362

Original Contact foo khon pu
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 01/27/2003
Decision Date 03/25/2003
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