POWDER-FREE VIVYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)


Device Classification Name

vinyl patient examination glove

510(k) Number K121157
Device Name POWDER-FREE VIVYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Applicant
SHIJAZHUANG JIUYUAN PLASTIC CO., LTD
rm 1606 bldg. 1
jianxiang yuan
beijing, 

CN

100083

Applicant Contact chu xiaoan
Correspondent
SHIJAZHUANG JIUYUAN PLASTIC CO., LTD
rm 1606 bldg. 1
jianxiang yuan
beijing, 

CN

100083

Correspodent Contact chu xiaoan
Regulation Number 880.6250
Classification Product Code
LYZ  
Date Received 04/16/2012
Decision Date 08/02/2012
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