Playtex (Scented and Unscented) Sport Fresh Balance Tampons
FDA 510(k) K132819 · Playtex Manufacturing, Inc.
510(k) numberK132819
Submission
- Device name
- Playtex (Scented and Unscented) Sport Fresh Balance Tampons
- Applicant
- Playtex Manufacturing, Inc.
Allendale, NJ, US - Received
- September 9, 2013
- Decision date
- October 9, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K050067 | Femtex and Private Label Scented Plastic Applicator TamponsHIL · Traditional | First Quality Hygienic, Inc. | 02/01/2005SE |
More from First Quality Hygienic, Inc.
Questions and answers
When was Playtex (Scented and Unscented) Sport Fresh Balance Tampons cleared by the FDA?
Playtex (Scented and Unscented) Sport Fresh Balance Tampons (K132819) received a 510(k) decision of Substantially Equivalent on October 9, 2013, 30 days after the submission was received.
What is the product code of K132819?
The FDA product code is HIL – Tampon, Menstrual, Scented, Scented-Deodorized, a Class II (moderate risk) device regulated under 21 CFR 884.5460.