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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 K002175
Device Name NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR
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 Received07/19/2000
Decision Date 07/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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