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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name latex patient examination glove
510(k) Number K992419
Device Name ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR
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
Correspondent Contact E.J. Smith
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/20/1999
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
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