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FMC — Patient Examination Glove Class I

FDA Device Classification

Classification Details

Product Code
FMC
Device Class
Class I
Regulation Number
880.6250
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K042618la glove (m) sdn. bhdLAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLNovember 26, 2004
K014134supergrade healthcare products sdn. bhdPOWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)January 22, 2002
K992337mexpo intlBLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIMAugust 17, 1999
K932404safeskinNITRILE RUBBER POWDER-FREE EXAMINATION GLOVEMay 18, 1994
K932405safeskinNITRILE RUBBER EXAMINATION GLOVES (POWERED)May 18, 1994
K923175ulti-med intlSURGICAL INSTRUMENT KIT, DISPOSABLEJune 17, 1993
K920649wilde-usaCOMPASEPJuly 23, 1992
K915376sci-pharm scientific pharmaceuticalGLASION VARNISHJanuary 22, 1992
K905127success builders intlLATEX GLOVE APPLICATION AND REMOVAL SYSTEMJanuary 30, 1991
K905109tactyl technologiesPATIENT EXAMINATION GLOVE/HYPOALLERGENICNovember 21, 1990
K903746wembley rubber products (m)COMFIT, PATIENT EXAMINATION GLOVESSeptember 5, 1990
K902278fujian province jiu zhou groupPVC PATIENT EXAMINATION GLOVEAugust 29, 1990
K883805a and a medicalROCKET SEX CRIME KITJanuary 31, 1989
K885346daw shin industrial coNON-STERILE VINYL GLOVESJanuary 18, 1989
K882533sukas exportLATEX EXAMINATION GLOVEJuly 21, 1988
K882583b und j instrumentsLATEX EXAM GLOVES, NON-STERILEJuly 14, 1988
K840620marwood medicalTPN/CVP DRESSING CHANGE KITMay 30, 1984
K833758packaging technologiesP.T.I. DRESSING CHANGE TRAYSJanuary 26, 1984
K831964currie medical specialtiesCMS 2000 SERIES TPN KITSAugust 11, 1983
K831564ansellORTHOPEDIC SURGICAL GLOVEJuly 12, 1983