Playtex Slender Reg. Tampons & Deodorant Tampons
FDA 510(k) K852063 · Intl. Playtex, Inc.
510(k) numberK852063
Submission
- Device name
- Playtex Slender Reg. Tampons & Deodorant Tampons
- Applicant
- Intl. Playtex, Inc.
Paramus, NJ, US - Received
- May 13, 1985
- Decision date
- May 22, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K871197 | Playtex Tampons and Deodorant TamponsHIL · Traditional | 05/12/1987SE |
| K861738 | Playtex TamponsHIL · Traditional | 07/22/1986SE |
| K854258 | Playtex Light'N Gentle Unscented/Deodorant/Mini TaHIL · Traditional | 11/21/1985SE |
| K851356 | Playtex Super Tampons & Super Deodorant TamponsHEB · Traditional | 04/12/1985SE |
| K851355 | Playtex Super Plus Tampons & Deodorant TamponsHEB · Traditional | 04/12/1985SE |
| K782112 | Pads, Mini, MaxiHHD · Traditional | 01/08/1979SE |
| K782111 | Pads, Mini, Maxi DeodorantHHL · Traditional | 01/08/1979SE |
| K760425 | Tampon, Playtex 2 Version aHIL · Traditional | 09/13/1976SE |
| K760426 | Tampon, Playtex 2 Version BHIL · Traditional | 08/26/1976SE |
Questions and answers
When was Playtex Slender Reg. Tampons & Deodorant Tampons cleared by the FDA?
Playtex Slender Reg. Tampons & Deodorant Tampons (K852063) received a 510(k) decision of Substantially Equivalent on May 22, 1985, 9 days after the submission was received.
What is the product code of K852063?
The FDA product code is HEB – Tampon, Menstrual, Unscented, a Class II (moderate risk) device regulated under 21 CFR 884.5470.