HIL — Tampon, Menstrual, Scented, Scented-Deodorized Class II

FDA Device Classification

Classification Details

Product Code
HIL
Device Class
Class II
Regulation Number
884.5460
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Definition

A scented or scented-deodorized menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K132208ontex bvbaONTEX AND OTHERS PROPRIETARY NAMESApril 10, 2014
K132819playtex manufacturingPLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONSOctober 9, 2013
K120245playtexPLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONSJune 21, 2012
K111684playtex manufacturingPLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELDFebruary 3, 2012
K081555procter and gambleTAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTEDJune 27, 2008
K073662playtex productsPLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONSJanuary 17, 2008
K072376playtex productsPLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONSDecember 12, 2007
K070745playtex productsMODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK April 13, 2007
K060981playtex productsPLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONSMay 9, 2006
K051446first quality hygienicFEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONSJuly 14, 2005
K050067first quality hygienicFEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONSFebruary 1, 2005
K042773rostamROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONSNovember 23, 2004
K040312procter and gambleTAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUSMay 3, 2004
K032173first quality hygienicFEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONSSeptember 3, 2003
K032080rostamROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONSAugust 14, 2003
K022882playtex productsMODIFICATION TO PLAYTEX TAMPONS #24002September 16, 2002
K020200playtex productsPLAYTEX DEODORANT TAMPONS, MODEL 34802March 13, 2002
K020202playtex productsPLAYTEX DEODORANT TAMPONS, MODEL 34702March 12, 2002
K020201playtex productsPLAYTEX DEODORANT TAMPONS, MODEL 34902March 12, 2002
K011996procter and gambleTAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUSSeptember 19, 2001