HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE


Device Classification Name

latex patient examination glove

510(k) Number K992165
Device Name HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE
Applicant
PAMITEX INDUSTRIES SDN BHD
2 1/2 miles, jalan rasah
seremban, nageri sembilan
darul khusus, 

MY

70300

Applicant Contact said awang
Correspondent
PAMITEX INDUSTRIES SDN BHD
2 1/2 miles, jalan rasah
seremban, nageri sembilan
darul khusus, 

MY

70300

Correspodent Contact said awang
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 06/28/1999
Decision Date 08/25/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No