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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K043149
Device Name FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR)
Applicant
Firstline, LLC
760 Mcmurray Rd., Suite B
Buellton,  CA  93427
Applicant Contact COLETTE PERCHES
Correspondent
Firstline, LLC
760 Mcmurray Rd., Suite B
Buellton,  CA  93427
Correspondent Contact COLETTE PERCHES
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/15/2004
Decision Date 05/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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