Product Code: HIL FDA class 2 21 CFR 884.5460

Tampon, Menstrual, Scented, Scented-Deodorized

Obstetrics/Gynecology

The Scented Deodorized Menstrual Tampon is an intravaginal absorbent device designed to collect menstrual fluid, with the addition of fragrance or deodorizing agents. It is classified as FDA Class 2 (moderate risk) due to potential adverse reactions associated with added scents, requiring 510(k) premarket notification. The product code is HIL, regulated under 21 CFR 884.5460, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

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Basic Information

Product Code: HIL
Device Class: FDA class 2
Regulation Number: 884.5460
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 84 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K132208	ONTEX AND OTHERS PROPRIETARY NAMES	Apr 10, 2014	Substantially Equivalent	Ontex Bvba
K132819	PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS	Oct 09, 2013	Substantially Equivalent	Playtex Manufacturing, Inc.
K120245	PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS	Jun 21, 2012	Substantially Equivalent	Playtex, Inc.
K111684	PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD	Feb 03, 2012	Substantially Equivalent	Playtex Manufacturing, Inc.
K081555	TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED	Jun 27, 2008	Substantially Equivalent	Procter & Gamble Co.
K073662	PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS	Jan 17, 2008	Substantially Equivalent	Playtex Products, Inc.
K072376	PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS	Dec 12, 2007	Substantially Equivalent	Playtex Products, Inc.
K070745	MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS	Apr 13, 2007	Substantially Equivalent	Playtex Products, Inc.
K060981	PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS	May 09, 2006	Substantially Equivalent	Playtex Products, Inc.
K051446	FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS	Jul 14, 2005	Substantially Equivalent	First Quality Hygienic, Inc.
K050067	FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS	Feb 01, 2005	Substantially Equivalent	First Quality Hygienic, Inc.
K042773	ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS	Nov 23, 2004	Substantially Equivalent	Rostam , Ltd.
K040312	TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS	May 03, 2004	Substantially Equivalent	Procter & Gamble Co.
K032173	FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS	Sep 03, 2003	Substantially Equivalent	First Quality Hygienic, Inc.
K032080	ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS	Aug 14, 2003	Substantially Equivalent	Rostam , Ltd.
K022882	MODIFICATION TO PLAYTEX TAMPONS #24002	Sep 16, 2002	Substantially Equivalent	Playtex Products, Inc.
K020200	PLAYTEX DEODORANT TAMPONS, MODEL 34802	Mar 13, 2002	Substantially Equivalent	Playtex Products, Inc.
K020202	PLAYTEX DEODORANT TAMPONS, MODEL 34702	Mar 12, 2002	Substantially Equivalent	Playtex Products, Inc.
K020201	PLAYTEX DEODORANT TAMPONS, MODEL 34902	Mar 12, 2002	Substantially Equivalent	Playtex Products, Inc.
K011996	TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS	Sep 19, 2001	Substantially Equivalent	Procter & Gamble Co.
K011171	TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS	Jul 02, 2001	Substantially Equivalent	Procter & Gamble Co.
K982383	PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS	Aug 19, 1998	Substantially Equivalent	Playtex Products, Inc.
K971547	PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS	Jun 19, 1997	Substantially Equivalent	Playtex Products, Inc.
K964269	PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS	Nov 29, 1996	Substantially Equivalent	Playtime Products, Inc.
K961870	PLAYTEX SLIMFIT TAMPONS	Jun 19, 1996	Substantially Equivalent	Playtex Products, Inc.
K961456	PLAYTEX TAMPONS #10296	Jun 18, 1996	Substantially Equivalent	Playtime Products, Inc.
K953638	O.B. APPLICATOR TAMPONS	Oct 20, 1995	Substantially Equivalent	Personal Products Co.
K952344	SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS	Jul 28, 1995	Substantially Equivalent	Tambrands, Inc.
K950928	ULTIMATES SILK GLIDE TAMPONS	Mar 22, 1995	Substantially Equivalent	Playtime Products, Inc.
K941044	PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194	Jul 27, 1994	Substantially Equivalent	Playtex, Inc.
K941196	PLATEX TAMPONS MODEL NUMBER 07094	Apr 19, 1994	Substantially Equivalent	Playtex Family Products, Inc.
K940821	PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED	Mar 25, 1994	Substantially Equivalent	Playtex Family Products, Inc.
K936189	PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND SCENTED	Mar 07, 1994	Substantially Equivalent	Playtex Family Products, Inc.
K935276	PLAYTEX NON-DEODORANT TAMPONS, PLAYTEX DEODORANT TAMPONS	Mar 07, 1994	Substantially Equivalent	Playtex Family Products, Inc.
K934083	PLAYTEX ULTIMATES TAMPONS	Mar 07, 1994	Substantially Equivalent	Playtex Family Products, Inc.
K932909	PLAYTEX ULTIMATES TAMPONS	Mar 07, 1994	Substantially Equivalent	Playtex Family Products, Inc.
K932907	PLAYTEX ULTIMATES TAMPONS	Mar 07, 1994	Substantially Equivalent	Playtex Family Products, Inc.
K922834	TAMPONS, NATURAL ODOR PROT. VARIOUS ABSORBENCY	Sep 01, 1993	Substantially Equivalent	Playtex Family Products, Inc.
K924279	PLAYTEX FLUSHABLE TAMPONS, REGULAR, SUPER, SUPER +	May 21, 1993	Substantially Equivalent	Playtex Family Products, Inc.
K914438	PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS	Jan 02, 1992	Substantially Equivalent	Playtex Family Products, Inc.
K912002	PLAYTEX NON-DEODORANT/DEODORANT TAMPONS	Aug 12, 1991	Substantially Equivalent	Playtex Family Products, Inc.
K905378	PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS	Feb 11, 1991	Substantially Equivalent	Playtex Family Products, Inc.
K897012	SCENTED OR SCENTED DEODORIZED, UNSCENTED TAMPONS	Dec 22, 1989	Substantially Equivalent	Playtex Family Products, Inc.
K896115	TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER	Dec 13, 1989	Substantially Equivalent	Tambrands, Inc.
K891297	PLAYTEX PORTABLES NON-DEODORANT & DOED. TAMPONS	Jun 08, 1989	Substantially Equivalent	Playtex Family Products, Inc.
K884737	PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS	Jan 10, 1989	Substantially Equivalent	Playtex Family Products, Inc.
K881057	PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER	Mar 22, 1988	Substantially Equivalent	Playtex, Inc.
K880024	TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER PLUS	Mar 08, 1988	Substantially Equivalent	Tambrands, Inc.
K880023	TAMPAX COMPAK, COMPACT PLASTIC APPLI. REGU. TAMPON	Mar 02, 1988	Substantially Equivalent	Tambrands, Inc.
K880022	TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPON	Mar 02, 1988	Substantially Equivalent	Tambrands, Inc.
K873457	SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS	Jan 19, 1988	Substantially Equivalent	Procter & Gamble Mfg. Co.
K874509	PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL	Jan 07, 1988	Substantially Equivalent	Playtex, Inc.
K872261	TAMPAX DEODORANT TAMPON, SUPER	Jul 14, 1987	Substantially Equivalent	Tambrands, Inc.
K872260	TAMPAX DEODORANT TAMPON, SLENDER REGULAR	Jul 10, 1987	Substantially Equivalent	Tambrands, Inc.
K872259	TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER	Jul 10, 1987	Substantially Equivalent	Tambrands, Inc.
K872258	TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER PLUS	Jul 10, 1987	Substantially Equivalent	Tambrands, Inc.
K872257	TAMPAX PETAL SOFT DEODORANT TAMPON, REGULAR	Jul 10, 1987	Substantially Equivalent	Tambrands, Inc.
K872256	TAMPAX DEODORANT TAMPON, ORIGINAL REGULAR	Jul 10, 1987	Substantially Equivalent	Tambrands, Inc.
K872255	TAMPAX DEODORANT TAMPON, SUPER PLUS	Jul 10, 1987	Substantially Equivalent	Tambrands, Inc.
K871197	PLAYTEX TAMPONS AND DEODORANT TAMPONS	May 12, 1987	Substantially Equivalent	Intl. Playtex, Inc.
K864498	O.B.(TM) TAMPON	Jan 27, 1987	Substantially Equivalent	Personal Products Co.
K861738	PLAYTEX TAMPONS	Jul 22, 1986	Substantially Equivalent	Intl. Playtex, Inc.
K862353	TAMPAX TAMPONS, VARIOUS SIZES/TYPES (MODIFICATION)	Jul 09, 1986	Substantially Equivalent	Tambrands, Inc.
K854258	PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA	Nov 21, 1985	Substantially Equivalent	Intl. Playtex, Inc.
K843551	PLAYTEX BABY POWDER DEODORANT TAMPONS	Dec 03, 1984	Substantially Equivalent	Playtex, Inc.
K841155	DEODORANT SLENDER REG. TAMPONS	Mar 19, 1984	Unknown	Playtex, Inc.
K841154	PLAYTEX SLENDER REGULAR TAMPONS	Mar 19, 1984	Unknown	Playtex, Inc.
K830966	PLAYTEX TAMPONS	Apr 08, 1983	Substantially Equivalent	Playtex, Inc.
K812618	ASSURE NATURAL FIT TAMPON	Oct 02, 1981	Substantially Equivalent	Personal Products Co.
K812534	IMPROVED PLAYTEX TAMPON	Sep 21, 1981	Substantially Equivalent	Playtex, Inc.
K811389	PLAYTEX COTTON TAMPONS	Aug 07, 1981	Substantially Equivalent	Playtex, Inc.
K811387	PLAYTEX COMBINATION FIBER MODIFIED TAMP	Aug 07, 1981	Substantially Equivalent	Playtex, Inc.
K811660	PLAYTEX MODIFIED FIBER TAMPONS	Jul 16, 1981	Substantially Equivalent	Playtex, Inc.
K811386	PLAYTEX PROCESS MACHINERY CHANGE	Jul 10, 1981	Substantially Equivalent	Playtex, Inc.
K811214	ASSURE NATURAL FIT TAMPON	May 21, 1981	Substantially Equivalent	Personal Products Co.
K810143	TAMPAX DEODORANT TAMPONS	Mar 04, 1981	Substantially Equivalent	Tampax, Inc.
K800272	RELY DEODERANT TAMPON	Feb 26, 1980	Substantially Equivalent	Procter & Gamble Mfg. Co.
K792627	STERILIZATION PROCESS/MATERNITY PAD	Jan 28, 1980	Substantially Equivalent	Procter & Gamble Mfg. Co.
K781085	ASSURE NATURAL FIT TAMPON	Jul 17, 1978	Substantially Equivalent	Personal Products Co.
K780058	TAMPON, HEAVY DUTY, & STICK	Jan 26, 1978	Substantially Equivalent	Kimberly-Clark Corp.
K771012	ASSURE DEODORANT TAMPONS	Jun 24, 1977	Substantially Equivalent	Personal Products Co.
K761184	RELY TAMPON	Dec 17, 1976	Substantially Equivalent	Procter & Gamble Mfg. Co.
K760425	TAMPON, PLAYTEX 2 VERSION A	Sep 13, 1976	Substantially Equivalent	Intl. Playtex, Inc.
K760426	TAMPON, PLAYTEX 2 VERSION B	Aug 26, 1976	Substantially Equivalent	Intl. Playtex, Inc.