SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE


Device Classification Name

vinyl patient examination glove

510(k) Number K111857
Device Name SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE
Applicant
INMED GLOVES FACTORY
10-2 xing’an rd.
east, linqu,
weifang, shandong, 

CN

262600

Applicant Contact xiaobing li
Correspondent
INMED GLOVES FACTORY
10-2 xing’an rd.
east, linqu,
weifang, shandong, 

CN

262600

Correspodent Contact xiaobing li
Regulation Number 880.6250
Classification Product Code
LYZ  
Date Received 06/30/2011
Decision Date 09/21/2011
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