Playtex Ultimates Silk Glide Tampons #22894
FDA 510(k) K944064 · Playtex, Inc.
510(k) numberK944064
Submission
- Device name
- Playtex Ultimates Silk Glide Tampons #22894
- Applicant
- Playtex, Inc.
Paramus, NJ, US - Received
- August 19, 1994
- Decision date
- February 9, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HEB – Tampon, Menstrual, Unscented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5470
- Specialty
- Obstetrics/Gynecology
An unscented 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 HEB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252005 | Livi DeviceHEB · Traditional | Liviwell, Inc. | 03/20/2026SE |
| K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator…HEB · Special | Unibeauty (Hubei) Technology Co., Ltd. | 12/17/2025SE |
| K252939 | Cohitech Organic Cotton Compact Applicator TamponsHEB · Special | Cotton High Tech S.L. | 10/09/2025SE |
| K252613 | Unscented menstrual three-piece applicator tamponHEB · Special | Unibeauty (Hubei) Technology Co., Ltd. | 09/19/2025SE |
| K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator…HEB · Special | Unibeauty (Hubei) Technology Co., Ltd. | 08/13/2025SE |
| K242105 | SABA TamponsHEB · Traditional | Essity Higiene Y Salud Mexico. S.A. DE C.V. | 04/01/2025SE |
| K241064 | Unscented TamponHEB · Traditional | Shandong Intco Hygiene Products Co., Ltd. | 01/10/2025SE |
| K240708 | Organic Cotton Tampon; Organic Cotton PESCVcord TamponHEB · Traditional | Suzhou Borage Medical Technology Co., Ltd. | 05/10/2024SE |
| K232060 | TOSAMA Reusable ApplicatorHEB · Traditional | Tosama, D.O.O. | 04/12/2024SE |
| K232598 | Unscented Menstrual TamponHEB · Traditional | Unibeauty (Hubei) Technology Co., Ltd. | 12/15/2023SE |
More from Unibeauty (Hubei) Technology Co., Ltd.
| 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 |
| 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 |
| K843551 | Playtex Baby Powder Deodorant TamponsHIL · Traditional | 12/03/1984SE |
| K841155 | Deodorant Slender Reg. TamponsHIL · Traditional | 03/19/1984SESP |
| K841154 | Playtex Slender Regular TamponsHIL · Traditional | 03/19/1984SESP |
Questions and answers
When was Playtex Ultimates Silk Glide Tampons #22894 cleared by the FDA?
Playtex Ultimates Silk Glide Tampons #22894 (K944064) received a 510(k) decision of Substantially Equivalent on February 9, 1995, 174 days after the submission was received.
What is the product code of K944064?
The FDA product code is HEB – Tampon, Menstrual, Unscented, a Class II (moderate risk) device regulated under 21 CFR 884.5470.