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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 K000390
Device Name VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
Applicant
SGMP CO., LTD.
198 AVENUE DE LA D'EMERALD
SPARKS,  NV  89434
Applicant Contact JANNA P TUCKER
Correspondent
SGMP CO., LTD.
198 AVENUE DE LA D'EMERALD
SPARKS,  NV  89434
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/07/2000
Decision Date 04/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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