SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT


Device Classification Name

polymer patient examination glove

510(k) Number K991744
Device Name SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT
Applicant
SHIELD GLOVES MANUFACTURER (M) SDN BHD
p.o. box 4341
crofton, 
MD 
21114

Applicant Contact e. j. smith
Correspondent
SHIELD GLOVES MANUFACTURER (M) SDN BHD
p.o. box 4341
crofton, 
MD 
21114

Correspodent Contact e. j. smith
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 05/21/1999
Decision Date 06/23/1999
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