Modification to Playtex Tampons #24002
FDA 510(k) K022882 · Playtex Products, Inc.
510(k) numberK022882
Submission
- Device name
- Modification to Playtex Tampons #24002
- Applicant
- Playtex Products, Inc.
Allendale, NJ, US - Received
- August 30, 2002
- Decision date
- September 16, 2002
- 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 |
| 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 |
|---|---|---|
| K073662 | Playtex Gentile Glide, Playtex Gentile Glide Multipack TamponsHIL · Special | 01/17/2008SE |
| K072376 | Playtex Gentle Glide, Playtex Gentle Glide Multipack TamponsHIL · Traditional | 12/12/2007SE |
| K070745 | Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack TamponsHIL · Special | 04/13/2007SE |
| K061013 | Playtex Embrace Petite Breast PumpHGX · Traditional | 08/15/2006SE |
| K060981 | Playtex Sport Plastic, Playtex Sport Plastic Multipack TamponsHIL · Special | 05/09/2006SE |
| K032636 | Playtex Unscented Cardboard Applicator Tampon #13203 (Colored) and # 13203 PV…HEB · Traditional | 11/14/2003SE |
| K022594 | Playtex Breast PumpHGX · Traditional | 11/01/2002SE |
| K020200 | Playtex Deodorant Tampons, Model 34802HIL · Traditional | 03/13/2002SE |
| K020202 | Playtex Deodorant Tampons, Model 34702HIL · Traditional | 03/12/2002SE |
| K020201 | Playtex Deodorant Tampons, Model 34902HIL · Traditional | 03/12/2002SE |
Questions and answers
When was Modification to Playtex Tampons #24002 cleared by the FDA?
Modification to Playtex Tampons #24002 (K022882) received a 510(k) decision of Substantially Equivalent on September 16, 2002, 17 days after the submission was received.
What is the product code of K022882?
The FDA product code is HIL – Tampon, Menstrual, Scented, Scented-Deodorized, a Class II (moderate risk) device regulated under 21 CFR 884.5460.