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


Device Classification Name

vinyl patient examination glove

510(k) Number K111297
Device Name SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
Applicant
PREMIER MEDICAL GLOVES FACTORY
no. 8-2, xing’an rd.,
dongcheng, linqu
weifang, shandong, 

CN

262600

Applicant Contact liang zhao
Correspondent
PREMIER MEDICAL GLOVES FACTORY
no. 8-2, xing’an rd.,
dongcheng, linqu
weifang, shandong, 

CN

262600

Correspodent Contact liang zhao
Regulation Number 880.6250
Classification Product Code
LYZ  
Date Received 05/09/2011
Decision Date 06/16/2011
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