RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER


definition

Device Classification Name

latex patient examination glove

510(k) Number K002114
Device Name RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER
Original Applicant
PERUSAHAAN PELINDUNG GETAH (M) SDN BHD
empat, senawang industrial
estate, 70450 seremban, negeri
sembilan darul khusus malaysia, 

ML

Original Contact peter yew nieng choon
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 07/12/2000
Decision Date 08/11/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No