UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES


codes

Device Classification Name

polymer patient examination glove

510(k) Number K000688
Device Name UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES
Original Applicant
N.S. UNI-GLOVES SDN. BHD.
ug healthcare (usa) inc
2420 carson st. suite 125
torrance, 
CA 
90501

Original Contact robert d vander leek
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 02/29/2000
Decision Date 04/12/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No