PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)


Device Classification Name

latex patient examination glove

510(k) Number K021659
Device Name PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)
Original Applicant
P.T. HEALTHCARE GLOVINDO
jl. kol. yos sudarso k.m. 10
kawasan indusri medan
medan, 

ID

10340

Original Contact ellen hutapea
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 05/20/2002
Decision Date 08/12/2002
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