Ultimates Silk Glide Tampons
FDA 510(k) K950928 · Playtime Products, Inc.
510(k) numberK950928
Submission
- Device name
- Ultimates Silk Glide Tampons
- Applicant
- Playtime Products, Inc.
Paramus, NJ, US - Received
- March 1, 1995
- Decision date
- March 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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.
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| 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 |
|---|---|---|
| K993794 | Platex Oder Absorbing Gentle Glide, Slimfits and Silk Glide TamponsHEB · Traditional | 02/07/2000SE |
| K981760 | Playtex Silk Glide Odor Absorbing Flushable Cardboard Tampons #13598HEB · Traditional | 07/22/1998SE |
| K964269 | Playtex Tampons Gentle Glide Deordorant Tampons and Playtex/Gentle Glide Deodorant…HIL · Traditional | 11/29/1996SE |
| K961456 | Playtex Tampons #10296HIL · Traditional | 06/18/1996SE |
| K952394 | Playtex Tampons #13695HEB · Traditional | 08/21/1995SE |
| K923375 | Playskool SunglassesHQY · Traditional | 06/09/1993SE |
| K923374 | Various SunglassesHQY · Traditional | 06/09/1993SE |
Questions and answers
When was Ultimates Silk Glide Tampons cleared by the FDA?
Ultimates Silk Glide Tampons (K950928) received a 510(k) decision of Substantially Equivalent on March 22, 1995, 21 days after the submission was received.
What is the product code of K950928?
The FDA product code is HIL – Tampon, Menstrual, Scented, Scented-Deodorized, a Class II (moderate risk) device regulated under 21 CFR 884.5460.