PROTECTIVE LATEX POWDERED GLOVES


Device Classification Name

latex patient examination glove

510(k) Number K960277
Device Name PROTECTIVE LATEX POWDERED GLOVES
Applicant
HIGHACTIVE SDN. BHD.
lot 12-b, industrial area,
6 1/2 miles, jalan kepong
kuala lumpur, 

MY

52000

Applicant Contact chong yoon tat
Correspondent
HIGHACTIVE SDN. BHD.
lot 12-b, industrial area,
6 1/2 miles, jalan kepong
kuala lumpur, 

MY

52000

Correspodent Contact chong yoon tat
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 01/19/1996
Decision Date 05/15/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No