POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS)


information about

Device Classification Name

latex patient examination glove

510(k) Number K002701
Device Name POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS)
Original Applicant
ALLIANCE RUBBER PRODUCTS SDN. BHD.
lot 2716&2720, mk 7, kawasan
perindustrian bukit panchor
nibong tebal, pulau pinang, 

MY

14300

Original Contact chua hooi koon
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 08/30/2000
Decision Date 09/13/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No