Product code HIL
- Device name
- Tampon, Menstrual, Scented, Scented-Deodorized
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.5460
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132208 | ONTEX AND OTHERS PROPRIETARY NAMES | Ontex Bvba | 2014-04-10 |
| K132819 | PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS | Playtex Manufacturing, Inc. | 2013-10-09 |
| K120245 | PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS | Playtex, Inc. | 2012-06-21 |
| K111684 | PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD | Playtex Manufacturing, Inc. | 2012-02-03 |
| K081555 | TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED | Procter & Gamble Co. | 2008-06-27 |
| K073662 | PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS | Playtex Products, Inc. | 2008-01-17 |
| K072376 | PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS | Playtex Products, Inc. | 2007-12-12 |
| K070745 | MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS | Playtex Products, Inc. | 2007-04-13 |
| K060981 | PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS | Playtex Products, Inc. | 2006-05-09 |
| K051446 | FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS | First Quality Hygienic, Inc. | 2005-07-14 |
| K050067 | FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS | First Quality Hygienic, Inc. | 2005-02-01 |
| K042773 | ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS | Rostam , Ltd. | 2004-11-23 |
| K040312 | TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS | Procter & Gamble Co. | 2004-05-03 |
| K032173 | FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS | First Quality Hygienic, Inc. | 2003-09-03 |
| K032080 | ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS | Rostam , Ltd. | 2003-08-14 |
| K022882 | MODIFICATION TO PLAYTEX TAMPONS #24002 | Playtex Products, Inc. | 2002-09-16 |
| K020200 | PLAYTEX DEODORANT TAMPONS, MODEL 34802 | Playtex Products, Inc. | 2002-03-13 |
| K020201 | PLAYTEX DEODORANT TAMPONS, MODEL 34902 | Playtex Products, Inc. | 2002-03-12 |
| K020202 | PLAYTEX DEODORANT TAMPONS, MODEL 34702 | Playtex Products, Inc. | 2002-03-12 |
| K011996 | TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS | Procter & Gamble Co. | 2001-09-19 |
| K011171 | TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS | Procter & Gamble Co. | 2001-07-02 |
| K982383 | PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS | Playtex Products, Inc. | 1998-08-19 |
| K971547 | PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS | Playtex Products, Inc. | 1997-06-19 |
| K964269 | PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS | Playtime Products, Inc. | 1996-11-29 |
| K961870 | PLAYTEX SLIMFIT TAMPONS | Playtex Products, Inc. | 1996-06-19 |
| K961456 | PLAYTEX TAMPONS #10296 | Playtime Products, Inc. | 1996-06-18 |
| K953638 | O.B. APPLICATOR TAMPONS | Personal Products Co. | 1995-10-20 |
| K952344 | SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS | Tambrands, Inc. | 1995-07-28 |
| K950928 | ULTIMATES SILK GLIDE TAMPONS | Playtime Products, Inc. | 1995-03-22 |
| K941044 | PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194 | Playtex, Inc. | 1994-07-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00073010631632 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2021-01-22 |
| 00073010631601 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2021-01-22 |
| 00037000118916 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2019-12-13 |
| 00073010024403 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2019-12-13 |
| 00073010024243 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2018-12-20 |
| 00073010024236 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2018-12-20 |
| 00073010023789 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2018-06-27 |
| 00037000757351 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2018-01-18 |
| 00073010023376 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2018-01-18 |
| 00073010023130 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2017-04-14 |
| 00037000721536 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2016-10-25 |
| 00073010022805 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2016-10-25 |
| 00050428259184 | CVS HEALTH TAMPONS | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2016-09-24 |
| 00050428397190 | CVS HEALTH TAMPONS | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2016-09-24 |
| 00036800770218 | TopCare Tampons | Topco Associates, LLC | 2016-09-20 |
| 00050428354629 | CVS Health Tampons | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2016-09-20 |
| 00050428352304 | CVS Health Tampons | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2016-09-20 |
| 00050428344590 | CVS Health Tampons | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2016-09-20 |
| 00041220906833 | H-E-B Tampons | H. E. BUTT GROCERY COMPANY | 2016-09-20 |
| 00041220255672 | H-E-B Tampons | H. E. BUTT GROCERY COMPANY | 2016-09-20 |
| 00041220032020 | H-E-B Tampons | H. E. BUTT GROCERY COMPANY | 2016-09-20 |
| 00041220032013 | H-E-B Tampons | H. E. BUTT GROCERY COMPANY | 2016-09-20 |
| 00036800395282 | TopCare Tampons | Topco Associates, LLC | 2016-09-20 |
| 00073010003767 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2016-09-15 |
| 00073010006096 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2016-09-15 |
| 00073010365193 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2016-09-15 |
| 00073010378537 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2016-09-15 |
| 00073010478480 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2016-09-15 |
| 00073010565418 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2016-09-15 |
| 00041520039934 | CareOne Tampons | Ahold U.S.A., Inc. | 2016-09-08 |