ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR


Device Classification Name

latex patient examination glove

510(k) Number K992417
Device Name ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR
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 07/20/1999
Decision Date 09/13/1999
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