PRE-POWDERED LATEX SURGEON’S GLOVES


Device Classification Name

surgeon’s gloves

510(k) Number K023515
Device Name PRE-POWDERED LATEX SURGEON’S GLOVES
Original Applicant
SANREA HEALTHCARE PRIVATE LIMITED
cochin special economic zone
kakkanad, cochin
kerala, 

IN

682037

Original Contact jose paul m
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 10/21/2002
Decision Date 01/16/2003
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