UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)


Device Classification Name

latex patient examination glove

510(k) Number K010879
Device Name UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Original Applicant
N.S. UNI-GLOVES SDN. BHD.
2420 carson st.
suite 125
torrence, 
CA 
90501

Original Contact robert d vander leek
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 03/23/2001
Decision Date 05/10/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No