GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT LABELING CLAIM 50UG/G OR LESS)


Device Classification Name

latex patient examination glove

510(k) Number K022343
Device Name GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT LABELING CLAIM 50UG/G OR LESS)
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 07/19/2002
Decision Date 09/16/2002
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