ALCATRON AND / OR MULTIPLE BRAND


Device Classification Name

vinyl patient examination glove

510(k) Number K112222
Device Name ALCATRON AND / OR MULTIPLE BRAND
Applicant
ALCATRON GLOVES FACTORY
no. 12-1, xing’an rd east
linqu, weifang
shandong, 

CN

262600

Applicant Contact shuqin gao
Correspondent
ALCATRON GLOVES FACTORY
no. 12-1, xing’an rd east
linqu, weifang
shandong, 

CN

262600

Correspodent Contact shuqin gao
Regulation Number 880.6250
Classification Product Code
LYZ  
Date Received 08/02/2011
Decision Date 10/27/2011
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