DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)


Device Classification Name

latex patient examination glove

510(k) Number K000838
Device Name DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS 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 03/14/2000
Decision Date 10/23/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No