Product Code: HHL FDA class 2 21 CFR 884.5425

Pad, Menstrual, Scented, Scented-Deodorized

Obstetrics/Gynecology

The Scented Menstrual Pad is an external absorbent product worn against the body to collect menstrual fluid during menstruation, with the addition of fragrance or deodorizing substances. It is classified as FDA Class 2 (moderate risk) due to the potential for adverse reactions to added scent ingredients, and is regulated under 21 CFR 884.5425, within the Obstetrics/Gynecology specialty. The product code is HHL. No special risk flags apply beyond the Class 2 designation.

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FEI Numbers

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Basic Information

Product Code: HHL
Device Class: FDA class 2
Regulation Number: 884.5425
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

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).

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 57 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K962962	DEODORANT PANTY LINER	Oct 10, 1996	Substantially Equivalent	Paragon Trade Brands, Inc.
K962954	DEODORANT MAXI PAD	Oct 10, 1996	Substantially Equivalent	Paragon Trade Brands, Inc.
K962953	DEODORANT PANTY SHIELD	Oct 10, 1996	Substantially Equivalent	Paragon Trade Brands, Inc.
K961119	CAREFREE PANTYLINERS	Apr 17, 1996	Substantially Equivalent	Personal Products Co.
K913238	ALWAYS, UNSCENTED MENSTRUAL PAD	Sep 23, 1991	Substantially Equivalent	Procter & Gamble Co.
K913237	ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD	Sep 23, 1991	Substantially Equivalent	Procter & Gamble Co.
K891473	TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO	Jun 07, 1989	Substantially Equivalent	Tambrands, Inc.
K890655	NEW FREEDOM THIN DEODORANT MAXI PADS	May 01, 1989	Substantially Equivalent	Kimberly-Clark Corp.
K884951	TAMPAX ULTRAFIT PANTY SHIELDS, DEODORANT	Jan 10, 1989	Substantially Equivalent	Tambrands, Inc.
K884446	MAXITHINS SUPER PADS, DEODORANT	Dec 20, 1988	Substantially Equivalent	Tambrands, Inc.
K884445	MAXITHINS PANTY SHIELDS, DEODORANT	Dec 05, 1988	Substantially Equivalent	Tambrands, Inc.
K884444	MAXITHINS REGULAR PADS, DEODORANT	Dec 05, 1988	Substantially Equivalent	Tambrands, Inc.
K884429	ALWAYS SCENTED OR SCENTED DEODORIZED MENSTRUAL PAD	Dec 02, 1988	Substantially Equivalent	Procter & Gamble Co.
K882094	GARDS DEODORANT SANITARY NAPKIN	Sep 22, 1988	Substantially Equivalent	Hospital Specialty Co.
K870066	KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS	Jun 19, 1987	Substantially Equivalent	Cascades Psh, Inc.
K864673	UNSCENTED MENSTRUAL PAD	Jan 21, 1987	Substantially Equivalent	Procter & Gamble Mfg. Co.
K864187	KOTEX (R) GOODNITES	Dec 11, 1986	Substantially Equivalent	Kimberly-Clark Corp.
K862675	MODIFIED DEODORANT MAXITHINS PANTY SHIELDS	Aug 18, 1986	Substantially Equivalent	Tambrands, Inc.
K862678	MODIFIED REGULAR DEODORANT MAXITHINS PADS	Aug 15, 1986	Substantially Equivalent	Tambrands, Inc.
K862676	MODIFIED SUPER DEODORANT MAXITHINS PADS	Aug 15, 1986	Substantially Equivalent	Tambrands, Inc.
K862285	KOTEX LIGHTDAYS DEODORANT PANTILINERS	Jul 08, 1986	Substantially Equivalent	Kimberly-Clark Corp.
K853000	SCENTED ALWAYS PANTILINERS	Sep 06, 1985	Substantially Equivalent	Procter & Gamble Mfg. Co.
K852225	BELIEVE DEODORANT LABIAL PADS	Aug 13, 1985	Substantially Equivalent	Kimberly-Clark Corp.
K850956	ALWAYS MAXIPADS - SCENTED	May 14, 1985	Substantially Equivalent	Procter & Gamble Mfg. Co.
K850939	ALWAYS SUPER MAXIPAD-SCENTED	May 14, 1985	Substantially Equivalent	Procter & Gamble Mfg. Co.
K844975	SCENTED BREATHABLE MINI-SHIELD PRIVATE LABEL BRAND	Feb 25, 1985	Substantially Equivalent	I.C.D. Industries, Inc.
K843960	DEODORANT MAXITHINS BODY-SHAPED PANTY SHIELDS	Nov 07, 1984	Substantially Equivalent	Tambrands, Inc.
K843959	DEODORANT REGULAR MAXITHINS BODY-SHAPED MAXI PADS	Nov 07, 1984	Substantially Equivalent	Tambrands, Inc.
K843958	DEODORANT SUPER MAXITHINS BODY-SHAPED MAXI PADS	Nov 07, 1984	Substantially Equivalent	Tambrands, Inc.
K843886	SCENTED BREATHABLE PRIVATE LABEL MINI-SH	Oct 25, 1984	Substantially Equivalent	I.C.D. Industries, Inc.
K843155	SURE & NATURAL DEODORANT MAXI-SHIELD	Aug 24, 1984	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K841312	ASSURE-BREATHABLE PANTY LINERS/SCENT	Aug 20, 1984	Substantially Equivalent	Personal Products Co.
K842764	SCENTED MENSTRUAL PAD	Aug 10, 1984	Substantially Equivalent	Procter & Gamble Mfg. Co.
K834564	MENSTRUAL PADS	Mar 30, 1984	Substantially Equivalent	Probel-U.S., Inc.
K834302	STAYFREE* DEODORANT MAXI-PADS	Jan 17, 1984	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K834131	SCENTED MENSTRUAL PAD	Dec 29, 1983	Substantially Equivalent	Procter & Gamble Mfg. Co.
K832973	TAMPAX SUPER DEODORANT MAXITHINS	Nov 28, 1983	Substantially Equivalent	Tampax, Inc.
K832972	REGULAR DEODORANT MAXITHINS PADS	Nov 28, 1983	Substantially Equivalent	Tampax, Inc.
K832971	DEODORANT MAXITHINS PANTY SHIELD	Nov 28, 1983	Substantially Equivalent	Tampax, Inc.
K832382	CAREFREE * PANTY SHIELDS-REG/DEOR	Aug 12, 1983	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K831691	PRIVATE LABEL DEODORANT MAXISHIELD	Jun 30, 1983	Substantially Equivalent	Int'L Consumer Disposables
K831693	MAXI PADS SCENTED DEODORIZED	Jun 16, 1983	Substantially Equivalent	Int'L Consumer Disposables
K830630	PRIVATE LABE/ DEODORANT MAXIPAD	Apr 18, 1983	Substantially Equivalent	Int'L Consumer Disposables
K830144	PANTY-LINERS SCENTED	Jan 21, 1983	Substantially Equivalent	Procter & Gamble Mfg. Co.
K823478	SCENTED MENSTRUAL PADS	Jan 18, 1983	Substantially Equivalent	Procter & Gamble Mfg. Co.
K821375	DEODORANT SURE & NATURAL MAXISHIELDS	Jun 01, 1982	Substantially Equivalent	Personal Products Co.
K812403	SCENTED MENSTRUAL PADS	Sep 09, 1981	Substantially Equivalent	Procter & Gamble Mfg. Co.
K811868	SCENTED MENSTRUAL PADS	Jul 16, 1981	Substantially Equivalent	Procter & Gamble Mfg. Co.
K802277	KOTEX LIGHTDAYS DEODORANT PANTILINERS	Oct 10, 1980	Substantially Equivalent	Kimberly-Clark Corp.
K801024	ODOR MASKING AGENT IN BOUNDARY OBSTETRI.	Jul 28, 1980	Substantially Equivalent	The Buckeye Cellulose Corp.
K801358	NEW FREEDOM ANYDAY PANTILINERS	Jul 21, 1980	Substantially Equivalent	Kimberly-Clark Corp.
K792195	DEODORANT CAREFREE PANTY SHIELDS	Nov 16, 1979	Substantially Equivalent	Personal Products Co.
K791433	KOTEX LIGHTDAYS DEODORANT PATILINERS	Sep 17, 1979	Substantially Equivalent	Kimberly-Clark Corp.
K782111	PADS, MINI, MAXI DEODORANT	Jan 08, 1979	Substantially Equivalent	Intl. Playtex, Inc.
K771547	PETITES BETWEEN-PERIOD PROTECTORS	Sep 20, 1977	Substantially Equivalent	3M Company
K761233	STAYFREE MAXI PADS	Dec 17, 1976	Substantially Equivalent	Personal Products Co.
K760853	STAYFREE DEODORANT MINI-PADS	Nov 11, 1976	Substantially Equivalent	Personal Products Co.