ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM


Device Classification Name

latex patient examination glove

510(k) Number K991745
Device Name ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM
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
LYY  
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