CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN)


Device Classification Name

latex patient examination glove

510(k) Number K010854
Device Name CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN)
Original Applicant
PROTECTION GLOVES SDN. BHD.
lot no. 236, batu 2 1/2,
jalan yong peng
chaah, johor, 

MY

85400

Original Contact richard chooi
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 03/22/2001
Decision Date 06/13/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No