POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB


Device Classification Name

latex patient examination glove

510(k) Number K030112
Device Name POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB
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
LYY  
Date Received 01/13/2003
Decision Date 02/27/2003
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