MULTIPLE NAME


Device Classification Name

polymer patient examination glove

510(k) Number K103337
Device Name MULTIPLE NAME
Applicant
IDEAL QUALITY SDN., BHD.
lot 2796, 17 1/2 miles
jalan kapar
klang, 

MY

42200

Applicant Contact sh tan
Correspondent
IDEAL QUALITY SDN., BHD.
lot 2796, 17 1/2 miles
jalan kapar
klang, 

MY

42200

Correspodent Contact sh tan
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 11/15/2010
Decision Date 02/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No