SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)


Device Classification Name

polymer patient examination glove

510(k) Number K111300
Device Name SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)
Applicant
PT. MAHAKARYA INTI BUANA
dalu 10, deli serdang
t. morawa
sumatera utara, 

ID

20362

Applicant Contact lina ng
Correspondent
PT. MAHAKARYA INTI BUANA
dalu 10, deli serdang
t. morawa
sumatera utara, 

ID

20362

Correspodent Contact lina ng
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 05/09/2011
Decision Date 08/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No