GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE


Device Classification Name

latex patient examination glove

510(k) Number K030273
Device Name GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE
Original Applicant
PT. WRP BUANA MULTICORPORA
jalan jermal #20b, kelurahan
sei mati, medan labuhan km 17
medan, 

ID

20252

Original Contact ng poy sin
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 01/27/2003
Decision Date 03/26/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No