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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 K991743
Device Name ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O
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 Received05/21/1999
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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