SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS)

Device Classification Name

vinyl patient examination glove

510(k) Number K111012
Device Name SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS)
Applicant
TRUE GLOVE FACTORY
no.6-1 xingan road east, linqu
weifang, shandong, 

CN

262600
Applicant Contact frank yang
Correspondent
TRUE GLOVE FACTORY
no.6-1 xingan road east, linqu
weifang, shandong, 

CN

262600
Correspodent Contact frank yang
Regulation Number 880.6250
Classification Product Code
LYZ  
Date Received 04/12/2011
Decision Date 07/06/2011
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital
statement

statement

Type Traditional
Reviewed by Third Party No
Combination Product

No