POWDERFREE LATEX SURGEON’S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS


definition

Device Classification Name

surgeon’s gloves

510(k) Number K000896
Device Name POWDERFREE LATEX SURGEON’S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS
Original Applicant
FITCO DIPPED PRODUCTS PVT. LTD
14-a cochin export processing
zone, kakkanand, kochi
kerala, 

IN

682 030

Original Contact joseph j e pereira
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 03/20/2000
Decision Date 05/03/2000
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