POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE


Device Classification Name

polymer patient examination glove

510(k) Number K111772
Device Name POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE
Applicant
KOSSAN LATEX INDUSTRIES(M)SDN BHD
lot 6129,jalan haji abdul
manan, off jalan meru
klang, selangor d.e., 

MY

41050

Applicant Contact cho sow fong
Correspondent
KOSSAN LATEX INDUSTRIES(M)SDN BHD
lot 6129,jalan haji abdul
manan, off jalan meru
klang, selangor d.e., 

MY

41050

Correspodent Contact cho sow fong
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 06/23/2011
Decision Date 10/20/2011
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