HHL — Pad, Menstrual, Scented, Scented-Deodorized Class II

FDA Device Classification

Classification Details

Product Code
HHL
Device Class
Class II
Regulation Number
884.5425
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Definition

Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, including those intended as intralabial pads or reusable menstrual pads. These are made with materials that do not meet the requirements for Class 1 per 21 CFR 884.5425(b).

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K962953paragon trade brandsDEODORANT PANTY SHIELDOctober 10, 1996
K962954paragon trade brandsDEODORANT MAXI PADOctober 10, 1996
K962962paragon trade brandsDEODORANT PANTY LINEROctober 10, 1996
K961119personal productsCAREFREE PANTYLINERSApril 17, 1996
K913237procter and gambleALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PADSeptember 23, 1991
K913238procter and gambleALWAYS, UNSCENTED MENSTRUAL PADSeptember 23, 1991
K891473tambrandsTAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIOJune 7, 1989
K890655kimberly-clarkNEW FREEDOM THIN DEODORANT MAXI PADSMay 1, 1989
K884951tambrandsTAMPAX ULTRAFIT PANTY SHIELDS, DEODORANTJanuary 10, 1989
K884446tambrandsMAXITHINS SUPER PADS, DEODORANTDecember 20, 1988
K884444tambrandsMAXITHINS REGULAR PADS, DEODORANTDecember 5, 1988
K884445tambrandsMAXITHINS PANTY SHIELDS, DEODORANTDecember 5, 1988
K884429procter and gambleALWAYS SCENTED OR SCENTED DEODORIZED MENSTRUAL PADDecember 2, 1988
K882094hospital specialtyGARDS DEODORANT SANITARY NAPKINSeptember 22, 1988
K870066cascades pshKAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADSJune 19, 1987
K864673procter and gamble mfgUNSCENTED MENSTRUAL PADJanuary 21, 1987
K864187kimberly-clarkKOTEX (R) GOODNITESDecember 11, 1986
K862675tambrandsMODIFIED DEODORANT MAXITHINS PANTY SHIELDSAugust 18, 1986
K862678tambrandsMODIFIED REGULAR DEODORANT MAXITHINS PADSAugust 15, 1986
K862676tambrandsMODIFIED SUPER DEODORANT MAXITHINS PADSAugust 15, 1986