HIL · Tampon, Menstrual, Scented, Scented-Deodorized
Obstetrics/Gynecology · 21 CFR 884.5460 · Class 2
Overview
| Product Code | HIL |
|---|---|
| Device Name | Tampon, Menstrual, Scented, Scented-Deodorized |
| Regulation | 21 CFR 884.5460 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A scented or scented deodorized menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 84)
Showing 20 most recent of 84 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K132208 | ONTEX AND OTHERS PROPRIETARY NAMES | Ontex Bvba | Apr 10, 2014 | SESE |
| K132819 | PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS | Playtex Manufacturing, Inc. | Oct 9, 2013 | SESE |
| K120245 | PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS | Playtex, Inc. | Jun 21, 2012 | SESE |
| K111684 | PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD | Playtex Manufacturing, Inc. | Feb 3, 2012 | SESE |
| K081555 | TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED | Procter & Gamble Co. | Jun 27, 2008 | SESE |
| K073662 | PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS | Playtex Products, Inc. | Jan 17, 2008 | SESE |
| K072376 | PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS | Playtex Products, Inc. | Dec 12, 2007 | SESE |
| K070745 | MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS | Playtex Products, Inc. | Apr 13, 2007 | SESE |
| K060981 | PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS | Playtex Products, Inc. | May 9, 2006 | SESE |
| K051446 | FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS | First Quality Hygienic, Inc. | Jul 14, 2005 | SESE |
| K050067 | FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS | First Quality Hygienic, Inc. | Feb 1, 2005 | SESE |
| K042773 | ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS | Rostam , Ltd. | Nov 23, 2004 | SESE |
| K040312 | TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS | Procter & Gamble Co. | May 3, 2004 | SESE |
| K032173 | FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS | First Quality Hygienic, Inc. | Sep 3, 2003 | SESE |
| K032080 | ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS | Rostam , Ltd. | Aug 14, 2003 | SESE |
| K022882 | MODIFICATION TO PLAYTEX TAMPONS #24002 | Playtex Products, Inc. | Sep 16, 2002 | SESE |
| K020200 | PLAYTEX DEODORANT TAMPONS, MODEL 34802 | Playtex Products, Inc. | Mar 13, 2002 | SESE |
| K020202 | PLAYTEX DEODORANT TAMPONS, MODEL 34702 | Playtex Products, Inc. | Mar 12, 2002 | SESE |
| K020201 | PLAYTEX DEODORANT TAMPONS, MODEL 34902 | Playtex Products, Inc. | Mar 12, 2002 | SESE |
| K011996 | TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS | Procter & Gamble Co. | Sep 19, 2001 | SESE |
Top Applicants
- Playtex Family Products, Inc. — 15 clearances
- Playtex, Inc. — 13 clearances
- Tambrands, Inc. — 13 clearances
- Playtex Products, Inc. — 11 clearances
- Personal Products Co. — 6 clearances
