Playtex Baby Powder Deodorant Tampons
FDA 510(k) K843551 · Playtex, Inc.
510(k) numberK843551
Submission
- Device name
- Playtex Baby Powder Deodorant Tampons
- Applicant
- Playtex, Inc.
Paramus, NJ, US - Received
- September 10, 1984
- Decision date
- December 3, 1984
- 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 |
|---|---|---|
| K120245 | Playtex Gentle Glide Scented Tampons and Playtex Gentle Glide Unscented TamponsHIL · Traditional | 06/21/2012SE |
| K980478 | Playtex Tampons #03498HEB · Traditional | 04/03/1998SE |
| K971174 | Playtex Gentle Glide Natural Odor Absorbent TamponsHEB · Traditional | 05/21/1997SE |
| K944064 | Playtex Ultimates Silk Glide Tampons #22894HEB · Traditional | 02/09/1995SE |
| K941044 | Playtex Ultimated Tampons Model Number 06194HIL · Traditional | 07/27/1994SE |
| K942418 | Playtex Tampons Model 13794HEB · Traditional | 07/08/1994SE |
| K881057 | Playtex Portable Non-Deod. & Deod Regular & SuperHIL · Traditional | 03/22/1988SE |
| K874509 | Playtex Non & Deodorant Tampons + Private LabelHIL · Traditional | 01/07/1988SE |
| K841155 | Deodorant Slender Reg. TamponsHIL · Traditional | 03/19/1984SESP |
| K841154 | Playtex Slender Regular TamponsHIL · Traditional | 03/19/1984SESP |
Questions and answers
When was Playtex Baby Powder Deodorant Tampons cleared by the FDA?
Playtex Baby Powder Deodorant Tampons (K843551) received a 510(k) decision of Substantially Equivalent on December 3, 1984, 84 days after the submission was received.
What is the product code of K843551?
The FDA product code is HIL – Tampon, Menstrual, Scented, Scented-Deodorized, a Class II (moderate risk) device regulated under 21 CFR 884.5460.