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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patient Examination Glove
510(k) Number K992337
Device Name BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA
Applicant
Mexpo Intl., Inc.
2671 Mccone Ave.
Hayward,,  CA  94545
Applicant Contact TIM THAI
Correspondent
Mexpo Intl., Inc.
2671 Mccone Ave.
Hayward,,  CA  94545
Correspondent Contact TIM THAI
Regulation Number880.6250
Classification Product Code
FMC  
Date Received07/13/1999
Decision Date 08/17/1999
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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