POWDERFREE POLYISOPRENE SURGICAL GLOVES


Device Classification Name

surgeon’s gloves

510(k) Number K112654
Device Name POWDERFREE POLYISOPRENE SURGICAL GLOVES
Applicant
PT. MEDISAFE TECHNOLOGIES
jl.batang kuis gg.tambak rejo
desa buntu bedimbar tj. morawa
medan, north sumatera, 

ID

20362

Applicant Contact anil taneja
Correspondent
PT. MEDISAFE TECHNOLOGIES
jl.batang kuis gg.tambak rejo
desa buntu bedimbar tj. morawa
medan, north sumatera, 

ID

20362

Correspodent Contact anil taneja
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 09/12/2011
Decision Date 02/17/2012
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