POWDER FREE LATEX SURGEON’S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER EXTRACTABLE PER GRAM


Device Classification Name

surgeon’s gloves

510(k) Number K023912
Device Name POWDER FREE LATEX SURGEON’S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER EXTRACTABLE PER GRAM
Original Applicant
SANREA HEALTHCARE PRIVATE LIMITED
cochin special economic zone
kakkanad, cochin
kerala, 

IN

682037

Original Contact joseph j e pereira
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 11/25/2002
Decision Date 02/11/2003
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