VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE)


Device Classification Name

vinyl patient examination glove

510(k) Number K103772
Device Name VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE)
Applicant
ADVANCED MEDICAL DEVICES FACTORY
no. 8-1 xing’an road
east linqu
weifang, shandong, 

CN

262600

Applicant Contact xingyuan wang
Correspondent
ADVANCED MEDICAL DEVICES FACTORY
no. 8-1 xing’an road
east linqu
weifang, shandong, 

CN

262600

Correspodent Contact xingyuan wang
Regulation Number 880.6250
Classification Product Code
LYZ  
Date Received 12/27/2010
Decision Date 02/25/2011
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