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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 K994131
Device Name AMBIDERM POWDERFREE LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM OF 50 MICROGRAMS OR LESS PER GRAM (BLACK COLORED)
Applicant
MEDTAXX PARTNERS
P.O. BOX 4341
CROFTON,  MD  21114
Applicant Contact E. J SMITH
Correspondent
MEDTAXX PARTNERS
P.O. BOX 4341
CROFTON,  MD  21114
Correspondent Contact E. J SMITH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/07/1999
Decision Date 02/07/2000
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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