POWDERED LATEX STERILE SURGICAL GLOVES


Device Classification Name

surgeon’s gloves

510(k) Number K992219
Device Name POWDERED LATEX STERILE SURGICAL GLOVES
Applicant
TG MEDICAL SDN BHD
lot 5091, jalan teratai, bt 5,
off jln meru
klang, selangor d.e., 

MY

41050

Applicant Contact wee-chai lim
Correspondent
TG MEDICAL SDN BHD
lot 5091, jalan teratai, bt 5,
off jln meru
klang, selangor d.e., 

MY

41050

Correspodent Contact wee-chai lim
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 07/01/1999
Decision Date 07/30/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No