BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES


Device Classification Name

vinyl patient examination glove

510(k) Number K022091
Device Name BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES
Original Applicant
TANGSHAN ZHONGHONG PULIN GROUP CO., LTD.
33235 transit ave.
union city, 
CA 
94587

Original Contact david hu
Regulation Number 880.6250
Classification Product Code
LYZ  
Date Received 06/27/2002
Decision Date 12/30/2002
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