HIL — Tampon, Menstrual, Scented, Scented-Deodorized Class II
FDA product code HIL covers "Tampon, Menstrual, Scented, Scented-Deodorized", a Class II medical device regulated under 21 CFR 884.5460. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- HIL
- Device Class
- Class II
- Regulation Number
- 884.5460
- Submission Type
- 510(k)
- 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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K132208 | Ontex Bvba | ONTEX AND OTHERS PROPRIETARY NAMES | Apr 10, 2014 |
| K132819 | Playtex Manufacturing | PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS | Oct 9, 2013 |
| K120245 | Playtex | PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS | Jun 21, 2012 |
| K111684 | Playtex Manufacturing | PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD | Feb 3, 2012 |
| K081555 | Procter And Gamble | TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED | Jun 27, 2008 |
| K073662 | Playtex Products | PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS | Jan 17, 2008 |
| K072376 | Playtex Products | PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS | Dec 12, 2007 |
| K070745 | Playtex Products | MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK… | Apr 13, 2007 |
| K060981 | Playtex Products | PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS | May 9, 2006 |
| K051446 | First Quality Hygienic | FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS | Jul 14, 2005 |
| K050067 | First Quality Hygienic | FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS | Feb 1, 2005 |
| K042773 | Rostam | ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS | Nov 23, 2004 |
| K040312 | Procter And Gamble | TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS | May 3, 2004 |
| K032173 | First Quality Hygienic | FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS | Sep 3, 2003 |
| K032080 | Rostam | ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS | Aug 14, 2003 |
| K022882 | Playtex Products | MODIFICATION TO PLAYTEX TAMPONS #24002 | Sep 16, 2002 |
| K020200 | Playtex Products | PLAYTEX DEODORANT TAMPONS, MODEL 34802 | Mar 13, 2002 |
| K020201 | Playtex Products | PLAYTEX DEODORANT TAMPONS, MODEL 34902 | Mar 12, 2002 |
| K020202 | Playtex Products | PLAYTEX DEODORANT TAMPONS, MODEL 34702 | Mar 12, 2002 |
| K011996 | Procter And Gamble | TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS | Sep 19, 2001 |