SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL


Device Classification Name

polymer patient examination glove

510(k) Number K103770
Device Name SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL
Applicant
SYNTEX HEALTHCARE PRODUCTS CO., LTD
3973 schaefer ave
chino, 
CA 
91710

Applicant Contact kathy liu
Correspondent
SYNTEX HEALTHCARE PRODUCTS CO., LTD
3973 schaefer ave
chino, 
CA 
91710

Correspodent Contact kathy liu
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 12/27/2010
Decision Date 04/21/2011
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