PRE-POWDERED LATEX ORTHOPEDIC SURGEON’S GLOVES


Device Classification Name

surgeon’s gloves

510(k) Number K030444
Device Name PRE-POWDERED LATEX ORTHOPEDIC SURGEON’S GLOVES
Applicant
PRIMUS GLOVES PRIVATE LTD.
plot no:14-a cochin special
economic zone
kakkanad, kochi, kerala, 

IN

682 030

Applicant Contact joseph j.e. pereira
Correspondent
PRIMUS GLOVES PRIVATE LTD.
plot no:14-a cochin special
economic zone
kakkanad, kochi, kerala, 

IN

682 030

Correspodent Contact joseph j.e. pereira
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 02/11/2003
Decision Date 06/05/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No