POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR


Device Classification Name

polymer patient examination glove

510(k) Number K112294
Device Name POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
Applicant
SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD.
12390 east end ave.
chino, 
CA 
91710

Applicant Contact frank liu
Correspondent
SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD.
12390 east end ave.
chino, 
CA 
91710

Correspodent Contact frank liu
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 08/10/2011
Decision Date 04/27/2012
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