MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED)


Device Classification Name

polymer patient examination glove

510(k) Number K022814
Device Name MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED)
Original Applicant
PT. SMART GLOVE INDONESIA
kawasan industri medan star j1
raya medan-lubuk pakam km.19
tg morawa-deli serdang utara, 

ID

20362

Original Contact foo khon pu
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 08/26/2002
Decision Date 02/19/2003
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