Playtex Light'N Gentle Unscented/Deodorant/Mini Ta
FDA 510(k) K854258 · Intl. Playtex, Inc.
510(k) numberK854258
Submission
- Device name
- Playtex Light'N Gentle Unscented/Deodorant/Mini Ta
- Applicant
- Intl. Playtex, Inc.
Paramus, NJ, US - Received
- October 22, 1985
- Decision date
- November 21, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HIL – Tampon, Menstrual, Scented, Scented-Deodorized
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5460
- Specialty
- Obstetrics/Gynecology
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.
Other 510(k)s with product code HIL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132208 | Ontex and Others Proprietary NamesHIL · Traditional | Ontex Bvba | 04/10/2014SE |
| K132819 | Playtex (Scented and Unscented) Sport Fresh Balance TamponsHIL · Special | Playtex Manufacturing, Inc. | 10/09/2013SE |
| K120245 | Playtex Gentle Glide Scented Tampons and Playtex Gentle Glide Unscented TamponsHIL · Traditional | Playtex, Inc. | 06/21/2012SE |
| K111684 | Playtex Sport (Unscented) ,(Scented) with OdorshieldHIL · Traditional | Playtex Manufacturing, Inc. | 02/03/2012SE |
| K081555 | Tampax Pearl Plastic Applicator Tampons, Scented and UnscentedHIL · Special | Procter & Gamble Co. | 06/27/2008SE |
| K073662 | Playtex Gentile Glide, Playtex Gentile Glide Multipack TamponsHIL · Special | Playtex Products, Inc. | 01/17/2008SE |
| K072376 | Playtex Gentle Glide, Playtex Gentle Glide Multipack TamponsHIL · Traditional | Playtex Products, Inc. | 12/12/2007SE |
| K070745 | Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack TamponsHIL · Special | Playtex Products, Inc. | 04/13/2007SE |
| K060981 | Playtex Sport Plastic, Playtex Sport Plastic Multipack TamponsHIL · Special | Playtex Products, Inc. | 05/09/2006SE |
| K051446 | Femtex and Private Label Opal Fresh Scented Plastic Applicator TamponsHIL · Traditional | First Quality Hygienic, Inc. | 07/14/2005SE |
More from First Quality Hygienic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K871197 | Playtex Tampons and Deodorant TamponsHIL · Traditional | 05/12/1987SE |
| K861738 | Playtex TamponsHIL · Traditional | 07/22/1986SE |
| K852063 | Playtex Slender Reg. Tampons & Deodorant TamponsHEB · Traditional | 05/22/1985SE |
| K851356 | Playtex Super Tampons & Super Deodorant TamponsHEB · Traditional | 04/12/1985SE |
| K851355 | Playtex Super Plus Tampons & Deodorant TamponsHEB · Traditional | 04/12/1985SE |
| K782112 | Pads, Mini, MaxiHHD · Traditional | 01/08/1979SE |
| K782111 | Pads, Mini, Maxi DeodorantHHL · Traditional | 01/08/1979SE |
| K760425 | Tampon, Playtex 2 Version aHIL · Traditional | 09/13/1976SE |
| K760426 | Tampon, Playtex 2 Version BHIL · Traditional | 08/26/1976SE |
Questions and answers
When was Playtex Light'N Gentle Unscented/Deodorant/Mini Ta cleared by the FDA?
Playtex Light'N Gentle Unscented/Deodorant/Mini Ta (K854258) received a 510(k) decision of Substantially Equivalent on November 21, 1985, 30 days after the submission was received.
What is the product code of K854258?
The FDA product code is HIL – Tampon, Menstrual, Scented, Scented-Deodorized, a Class II (moderate risk) device regulated under 21 CFR 884.5460.