STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES


definition

Device Classification Name

latex patient examination glove

510(k) Number K000891
Device Name STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES
Original Applicant
FITCO DIPPED PRODUCTS PVT. LTD
14-a cochin export processing
zone, kakkanand, kochin
kerala, 

IN

682 030

Original Contact joseph j e pereira
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 03/20/2000
Decision Date 04/28/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No