POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES


Device Classification Name

surgeon’s gloves

510(k) Number K030228
Device Name POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES
Original Applicant
PT. MEDISAFE TECHNOLOGIES
jl. kapt. pattimura no. 23
medan, north sumatra, 

ID

20153

Original Contact anil taneja
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 01/22/2003
Decision Date 03/14/2003
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