POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE


information about

Device Classification Name

latex patient examination glove

510(k) Number K001190
Device Name POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE
Original Applicant
KOSSAN LATEX INDUSTRIES (M) SDN. BHD.
lot 16632, 5-1/4 miles,
jalan meru
kelang, selangor, 

MY

41050

Original Contact lim kwan hwa
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 04/12/2000
Decision Date 05/23/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No